Webinar Central - Events Feed

Online Seminar Software

Thu, 22 Dec 2011 07:39:35 -0700

Start: 12/22/2011 - 08:28

End: 12/22/2013 - 08:28

The Online Seminar shows the Possibilities of the use of Desktop-Sharing Software. The Online-Seminar is free of charge an will contain the following topic.

How to Setup the Software.
Cost of the Software
Usage in the Sales and Marketing area.

The Webinar will held on request, the duration is approx. 30 Minutes

Further Information to the Online-Seminar

Business Mastery Series

Tue, 01 May 2012 09:39:44 -0700

Start: 04/02/2012 - 17:00

End: 07/24/2012 - 16:30

Learn more: www.practicepaysolutions.com/mastery

Join us for a free series of one-hour webinars with the a team of industry experts! We're presenting the less-covered, critical issues for small business owners, so you can reduce the time you spend on set-up and administration-- and focus on what really matters.

Can't attend live? We'll send you the call recordings so you can access valuable information and share the event with your community!

April 2nd: The Joy of Productivity with George Kao

April 16th: How to Create Profitable Referral Partnerships with Robert Notter

April 24th: Say Bye-Bye to Your Boring Bio with Nancy Juetten

May 15th: From Contacts to Contracts with Caterina Rando

May 22nd: Red Fire Profitability with Liz Goodgold

June 5th: Developing Contracts & Service Agreements with Tasha Cooper Coleman

June 19th: Outsourcing Secrets with Travis Greenlee

July 10th: Your Money Relationship = Your Business Success with Helen Kim

July 24th: How to Play a Bigger Marketing Game with Fabienne Fredrickson

Play Therapy Webinar Series

Tue, 08 May 2012 08:06:32 -0700

Start: 04/17/2012 - 09:03

End: 08/14/2012 - 09:03

Allan Gonsher and Kids Inc are pleased to a offer a series of Play Therapy Webinars. If your work with children, or want to work with children, these are workshops that you can not afford to miss. Each webinar workshop offers one hour of continuing education credit.

Understanding and Implementing the Medical Device Directive

Tue, 31 Jan 2012 23:26:02 -0700

Start: 05/17/2012 - 09:00

End: 05/18/2012 - 05:00

Course Description:

Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency.

This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants will have exercises that apply the principles and help solidify learning.

The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.

Marketing Your Webinar to Maximize Attendance

Mon, 05 Mar 2012 10:36:40 -0700

Start: 05/18/2012 - 10:00

End: 05/18/2012 - 11:00

Webinars are such a powerful tool that the marketing strategy merits specialized attention. There is no sense in developing a great webinar and then leaving the number of people who register completely up to fate. Every webinar whether it is for lead generation or for monetary gain, needs to be promoted to get the maximum potential benefit.

If your goal is to maximize attendance, and to get a few key webinar marketing insights, then this session is for you!

You Will Learn:

• 5 key tips for promoting your webinar (if you do nothing else, you must do these)
• Shortcomings that are prevalent in most webinars
• Maximizing not just registrations but attendance
• How to keep your audience engaged
• Effective assessment and follow-up strategies

A special bonus will also be supplied to all attendees who remain for the entire presentation.

Takeaways:
1. On-demand recording – available for 2 weeks following the webinar
2. 6 essential tips for great presentations (pdf)
3. Access to a special “By Invitation Only” webinar

Speaker: Bruce Newman, President, wwWebevents.com and The Productivity Institute, LLC

Free Webinar: Coping with the Change, Stress and Chaos of Military Life

Tue, 15 May 2012 13:54:00 -0700

Start: 05/21/2012 - 11:00

End: 05/21/2012 - 11:00

SalutetoSpouses.com will host a webinar, titled “Is it Supposed to be Like This: Coping with the Change, Stress and Chaos of Military Life,” on May 21 at 11 a.m. EDT and will highlight coping strategies military spouses can use to navigate the ups and downs of military life. The webinar is offered for free for all military spouses and their families.

The webinar will be led by combat veteran and Retired Army Colonel James (Jim) Martin. Colonel Martin spent 26 years in the Army Medical Department and is a licensed independent clinical social worker and a Board Certified Diplomate in Clinical Social Work and has more than 40 years of professional social work practice. As a combat veteran Colonel Martin is very in tune with the unique issues military families face. Additionally, both during his active and duty and since his retirement, he has served in many roles that address mental health issues among members of the military and their families. Some of his published work includes serving as one of the primary authors of “What We Know About Army Families: 2007 Update” (Technical Report & Video), contributing to the development of the “Army Chief of Staff’s White Paper on Army Families” and editing “The Gulf War and Mental Health: A Comprehensive Guide” (Praeger, 1996).

The webinar is offered for free by SalutetoSpouses.com. Military spouses interested in attending are invited to register at http://www.salutetospouses.com/webinars.

Supporting the Americans with Disabilities Act in Employment - Webinar By TrainHR

Thu, 22 Mar 2012 05:34:07 -0700

Start: 05/22/2012 - 10:00

End: 05/22/2012 - 10:00

Overview : The Americans with Disabilities Act was passed in 1990 and amended in 2008 (ADAAA). The Act prohibits discrimination against qualified individuals based on disability.

The section of the law we will cover is providing fair practices in employment and protection and support of qualified individuals with disabilities in the workplace. Complying with the law is essential, but actively pursuing this segment of the population is a plus both in the area of public policy and in finding a source of high quality, loyal and motivated employees.

Why should you attend: We will discuss an overview of the law, writing ADA compliant job descriptions, defining reasonable accommodations and methods to recruit qualified applicants. We will also cover government and private organizations which provide free programs, employee counseling and coaching and even tax credits in some cases. We will give examples of new breakthroughs in assistive technology that can enable employees to perform their work with ease. We will close with suggestions on how you can make compliance a positive experience by taking advantage of the resources available to enable individuals with disabilities to become gainfully employed.

Areas Covered in the Session:

Overview of the Americans with Disabilities Act
ADA Amendments Act (ADAAA) and Broader Protections
ADA Compliant Job Descriptions
Reasonable Accommodations
Assistive Technology at Work
Department of Labor and Private Programs
Tax Credits
Career Counseling and Assessments
Job Coaching and Training
Advantages to Employer
Advantages to Employee

Who Will Benefit:

Human Resources Professionals and administrators
Trainers
Public Relations and Marketing Professionals
Supervisors and all levels of Management

Supplier Controls to Meet Tougher U.S. FDA Requirements - Webinar By ComplianceOnline

Tue, 27 Mar 2012 03:15:12 -0700

Start: 05/22/2012 - 10:00

End: 05/22/2012 - 11:30

This 90-minute webinar on supplier controls will help you refine your supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.

Description:

Recent FDA statements and actions indicate the past ways of managing a company's supply chain / outsourcing will no longer be acceptable. Increasingly reports from the field indicate that the Agency is using high-profile cases to drive compliance to smaller companies and suppliers. CGMP compliance cannot be passed on to suppliers; however suppliers must meet specific CGMP requirements. Proof for "better science" is also a new expectation. "Business as usual" is never acceptable. Don't be caught of guard by these major shifts in emphasis.

This presentation will help you refine supplier management and audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program. This webinar will provide valuable assistance to all regulated companies in evaluating their existing supply chain control / compliance and vendor audits in light of the changes in the FDA's CGMP supplier management "paradigm". Once potential problem areas are identified, a company can evaluate / perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel

Fri, 13 Apr 2012 00:37:31 -0700

Start: 05/22/2012 - 10:00

End: 05/22/2012 - 10:00

Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong!

Areas Covered in the Session:
Why water myths develop
Impact of c-GMPs
Well-meaning but misguided precedents
Scientifically unchallenged traditions and benchmarking
Rule-hungry culture
Water System Microbial Control Myths
WFI from RO
Turbulent Flow and Flow Rate
Dead Leg Rules
Smooth Surfaces
In-Line Sterilizing Filters
Ozone
Microbial Enumeration Myths
Referee Methods
Thermophiles in Hot Systems
R2A, 35°C, 5 days
Test Filter Membrane Rating
Compendial Action Levels
TOC and Endotoxin as Microbial Count Correlates
Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:
Validation managers and personnel
Engineers involved in water system design and installation
Utility operators and their managers involved in maintaining and sanitizing water systems
QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
QA managers and personnel involved in investigations of excursions and preparing CAPAs
QC laboratory managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
Consultants and Troubleshooters

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

The Essentials of 1031 Exchanges

Tue, 15 May 2012 09:42:13 -0700

Start: 05/22/2012 - 11:00

End: 05/22/2012 - 11:50

This webinar will discuss the basics of the 1031 exchange process. Topics will include:

- Definition of a 1031 Exchange
- Like-Kind Defined
- Capital Gains & Boot
- Completing a successful 1031 Exchange
- Timeframes in a 1031 Exchange
- Selecting a Qualified Intermediary

The audio portion of the webinar will be broadcast over your computer's speakers and via telephone. You may choose to call in and ask questions or you may listen to the webinar over the internet and enter questions via text.

Not available in all U.S. jurisdictions.

Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals - Webinar By ComplianceOnline

Sun, 29 Apr 2012 22:57:25 -0700

Start: 05/23/2012 - 10:00

End: 05/23/2012 - 11:30

This 90-minute webinar will discuss the requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. It is designed to help the audience develop, maintain and implement adequate procedures.

Why Should You Attend:
The FDA's Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. Device firms are also subject to compliance to the FDA regulations of device recalls, reports of corrections and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.

This webinar is aimed at helping device industry understand how to develop, maintain and implement the procedures for MDR, recalls, corrections and removals and further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.

Areas Covered in the Seminar:

Relevant Statutes And FDA Regulations.
Regulatory Requirements For Medical Device Reporting (MDR).
How To Report A Medical Device Problem (MDR).
Reporting Requirements For The User Facilities, Manufacturers, And Importers.
Regulatory Requirements for Recall, Reports of Corrections And Removals.

DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel

Fri, 13 Apr 2012 00:44:40 -0700

Start: 05/23/2012 - 10:00

End: 05/23/2012 - 10:00

Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the MDD's TF/DD requirements, and evaluate the documents' differing purposes / goals.

Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should attend: Increasingly U.S. companies are going global and must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/B9DD. Being aware of the similarities and differences can further concurrent development and/or updates to both

Areas Covered In the Session:
The U.S. FDA's DHF
The EU's MDD and the Technical File / Design Dossier
Design Control vs. a Product 'Snapshot in Time'
DHF "Typical" Contents
TF / DD Expected Contents
Parallel Approaches to Documentation -- Teams
Future Directions
FDA and NB Audit Focus
Who will benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Marketing

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

FDA Warning Letter - Consent Decree Software Validation

Mon, 26 Mar 2012 22:51:10 -0700

Start: 05/23/2012 - 10:00

End: 05/23/2012 - 11:00

This FDA warning letter Webinar/training will discuss what to do to avoid additional software related compliance along with the response steps where the citations that directly or indirectly include automated system.

Why Should You Attend:

FDA inspectors are now being trained to evaluate software validation practices. Increasing use of automated manufacturing and quality systems have increased exposure. Most recalls can be traced back to computerized equipment, exposing the validation process to scrutiny. A third of recent warning letters included citations with respect to improper or ineffective validation. Computerized quality system tracking systems are subject to increased scrutiny during compliance and enforcement actions and hence incomplete software validations are ticking time bombs.

Once the FDA inspectors or Fedral marshalls have arrived, it's time to set up an effective software validation and software quality program - even if those were not the original citations that brought you to FDA's attention. Attend this Webinar if you have received, expect or fear an FDA-483, Warning Letter or Consent Decree. Learn steps that can be done proactively and forward plan to prevent additional software related compliance issues and how to prepare response where citations directly or indirectly include automated system.

Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance - Webinar By ComplianceOnline

Sun, 29 Apr 2012 21:59:17 -0700

Start: 05/23/2012 - 10:00

End: 05/23/2012 - 11:15

This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.

Why Should You Attend:

When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems.

This web seminar will give a good understanding on the regulatory requirements, and it will have recommendations and provide tools for effective implementation.

Hand-Outs:

For easy implementation, attendees will receive

SOP: Retrospective Validation of Computerized Systems
Checklist: Retrospective Validation of Computer Systems
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Learning Objectives:

Definition of legacy systems and retrospective validation.
FDA requirements and inspection practices.
Industry recommendations, e.g., from the GAMP.
Reviewing and updating the validation master plan for existing systems.
Documenting validation results for FDA/EU compliance.

Free Webinar: What Does an HR Department Do Exactly?

Tue, 15 May 2012 10:42:51 -0700

Start: 05/23/2012 - 12:00

End: 05/23/2012 - 12:00

Bryant & Stratton College Online will host “What Does an HR Department Do Exactly?”on Wednesday, May 23, from 12:00 to 1:00 p.m. EDT. The webinar will cover the wide variety of functions conducted by a human resources department.

Bryant & Stratton College Online Instructor Andrew Beyer will lead the webinar. Mr. Beyer has over 15 years of experience in the field of human resources and has served in both the private and retail sectors.

The webinar will cover topics such as: employment & recruiting, training & development, compensation, benefits, employee services, employee & community relations, personnel records, health & safety, and strategic planning. More specifically, Mr. Beyer will address HR issues like productivity enhancement, incentive pay, profit sharing, outplacement services, health & wellness and more. For current students the overview will provide a look at what to expect in a human resources career and give a general background of the field for students interested in enrolling in human resources courses online.

Upcoming Webinar on- Implement End-to-End ALM/SDLC from Customer Request to delivery with the Omnibus Integration Platform

Sun, 06 May 2012 21:59:18 -0700

Start: 05/23/2012 - 17:00

End: 05/23/2012 - 17:00

Eager to learn about Kovair Omnibus Integration Platform and the benefits of integration using the Kovair Omnibus, join this webinar by Atanu Majumdar ,'Sky' Basu, experts for Kovair on May 23, 2012 , 5:00 pm (IST) / 12:30 pm UK (WET) / 1:30 pm Germany (CET).

The A to Z’s of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems

Mon, 07 May 2012 03:15:02 -0700

Start: 05/24/2012 - 09:00

End: 05/25/2012 - 17:00

Course Description:

All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance.

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls.

Learning Objectives :-

At the completion of the course, attendees will be able to:

Understand the role of system design, maintenance and sanitization in controlling microbial levels in pharmaceutical water systems.
Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems.

Pre-Approval Statements and Representations by Pharmaceutical Manufacturers

Tue, 27 Mar 2012 03:44:15 -0700

Start: 05/24/2012 - 10:00

End: 05/24/2012 - 11:30

This 90-minute webinar will help you understand the problems that can occur with statements by pharmaceutical manufacturers directed to off-label uses of pharmaceuticals.

Why Should You Attend:

Off-label uses cannot be legally promoted. Promoting off-label uses may be viewed by FDA as actionable under the False Claims Act. Criminal and civil liabilities can be substantial for manufacturers. One recent settlement agreement with FDA went into the hundreds of millions of dollars.

Social media increases the chance for interaction between pharmaceutical manufacturers and patients (and others) like never before. Manufacturers are increasing in a position to responding to unsolicited requests for off-label information about prescription drugs and medical devices. The Federal Courts have offered some protections via interpretations of the First Amendment right to free speech.

This 90-minute training will help you understand the problems that can occur with statements by pharmaceutical manufacturers directed to off-label uses of pharmaceuticals. We will also discuss examples of recent cases dealing with communications about off-label uses of pharmaceuticals.

Affirmative Action Compliance and Your Recruiting Strategy: Pulling it together - Webinar By ComplianceOnline

Mon, 30 Apr 2012 01:03:18 -0700

Start: 05/24/2012 - 10:00

End: 05/24/2012 - 13:00

This 3-hr virtual seminar will take a deeper look at your recruiting practice and review the objective for affirmative action as it relates to this function in terms of ensuring compliance. The session also features a discussion about how to make the most of your recruiting technology so that you are prepared to meet the OFCCP’s recently heightened enforcement efforts.

Why Should You Attend:

Over the last 6 years, we seen the OFCCP become better funded, more sophisticated, and more motivated than ever to enforce affirmative action rules. Further, the changes initiated by the OFCCP have presented the greatest challenges for contractors with respect to compliance. In this new enforcement environment, government contractors are well advised to be prepared for more audits and more settlements, as there will be an aggressive increase in the OFCCP’s affirmative action enforcement efforts. From a risk perspective, your recruiting practices pose the greatest legal liability for your organization.

In this 3-hr training, we’ll take a practical look at what you should be doing now from a recruiting perspective to get and stay in compliance with the directives of a newly attentive OFCCP.

Learning Objectives:

Attendees will learn

How the OFCCP's enforcement mission statement may affect how you do business.
Why increased OFCCP enforcement could mean more discrimination lawsuits – and how to protect yourself .
The focus of the OFCCP's newly heightened enforcement efforts.
Rescission of two major guidance documents and what it means for your policies and practice.

Validation of Analytical Methods for FDA Compliance: Step-by-Step - Webinar By GlobalCompliancePanel

Fri, 13 Apr 2012 00:46:19 -0700

Start: 05/24/2012 - 10:00

End: 05/24/2012 - 10:00

Overview: Analytical methods should be validated to ensure reliability, consistency and accuracy of analytical data. Method validation has been a requirement of FDA and international regulations and accreditation standards such as ISO 17025 since many years. Most often the theory is well understood but there are many questions when validation experiments are designed, conducted, and documented.

This webinar will provide a good understanding on how to effectively prepare, conducts and document method validation experiments for FDA and ISO 17025 compliance.

Reference material for easy implementation:
SOP: Validation of Analytical Methods
Checklist: Validation of Analytical Methods
65-page Primer: Validation of Analytical Methods
Areas Covered in the Session:
FDA regulations and guidelines
Examples of warning letters and how to avoid them
USP Chapters and ICH Guides
Developing an SOP for method validation
Development of a validation plan for success
Prerequisites for method validation
Defining the minimum number of validation experiments that satisfy ICH, FDA and USP
Defining test conditions and acceptance limits
Verification of compendial methods according to USP <1226>
To revalidate or not after method changes
Transferring a method to routine according to USP <1224>
Seven most common method validation pitfalls and how to avoid them
Using software for automated method validation
Documentation for the FDA and for other agencies
Who Will Benefit:
Laboratory managers and supervisors
GLP/GCP/GMP auditors
ISO 17025 auditors
QA/QC managers and personnel
Analysts and other laboratory staff
Regulatory affairs
Training departments
Consultants

Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

An Overview of Risk Management and Risk Analysis Techniques in Clinical Trials - Webinar By ComplianceOnline

Fri, 27 Apr 2012 04:41:08 -0700

Start: 05/24/2012 - 10:00

End: 05/24/2012 - 11:30

This webinar will provide you with an overview of risk factors in clinical trials and discuss possible ways to mitigate, control, assess impact, and prevent them in your trial.

Why Should You Attend :

If you are currently involved in clinical trials either as a CRA, project manager, investigator or sponsor, this webinar will provide you with an overview of risk factors in clinical trials and possible ways to mitigate, control, assess impact, and prevent them in your trial. We would discuss the key elements of risk management such as planning, identification, quantification, action, measurement, outcome assessment, and post-implementation review of various types of risks. Also discussed will be best practices for risk analysis and prospective planning in the project plan. At the end of the course, you would be able to review your current project plan for potential issues or help address these factors in the future clinical trial project plans that you may create.
Learning Objectives:
At the end of the seminar, the attendees will be familiar with the following:

Most common issues with clinical trial initiation, execution and close-out.
Best practices for risk analysis, management and prevention.
Roles and responsibilities of various personnel in risk reduction.
Incorporating short-term and long-term measures in project plans to manage risk.
Processes to seek and document management decisions with regulatory implications.
Do’s and Don’ts for risk management of a clinical trial.

“No! I Don’t Want to Give My Child a Drug to Treat ADHD”: Complementary and Alternative Medicine for ADHD

Fri, 16 Mar 2012 07:01:13 -0700

Start: 05/24/2012 - 11:00

End: 05/24/2012 - 11:00

How do you respond to ADHD when medication isn’t an option? Explore complementary and alternative methods (CAM) for treating ADHD symptoms and learn what techniques may or may not provide the best outcomes for your patient.

Full Description:
In 2003, the Centers for Disease Control and Prevention found that 56.3% of the children with ADHD in the U.S. were using medication to treat their disorder. What about the other 44%? Despite evidence that 80-96% of children with ADHD
respond to stimulant medication treatment, many parents and guardians elect not to treat their children this way due to fears of side-effects, concerns about drug abuse later on in life, religious convictions, medical issues, and/or future career limitations.

This webinar uses an objective, evidence-based approach to discuss what treatment options are available when medication is not an option. Discover scientific research on complementary and alternative medicine (CAM) techniques and help determine the best treatment for your client.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
• Discuss evidence-based, complementary and alternative medicine (CAM) and why parents may not elect to medicate children diagnosed with ADHD
• Explore well designed, replicated double-blind research on effective CAM techniques
• Determine if a CAM technique is working and recognize those that are NOT shown to be effective in treating ADHD
• Design a scientifically investigated treatment plan for ADHD that does not include medication
• Explain why medication for ADHD is beneficial and can be combined with CAM techniques as part of an effective treatment strategy

Your Presenter:
KEVIN T. BLAKE, PhD, P.L.C., is a licensed psychologist and author with over 20 years of experience as a nationally recognized authority on learning disorders and ADHD in children, adolescents, and adults. This interest spurred from his own struggles overcoming a reading disorder/dyslexia and hearing impairment.

Dr. Blake serves as a member of the American Psychological Association, International Dyslexia Association, Children and Adults with Attention Deficit Disorders, Learning Disabilities Association, and the National Attention Deficit Disorder Association and was a 1991 delegate to the National Institute for Literacy’s “LEAD 2000 Congress,” where he advised Congress on diagnostic and remediation issues.

Disclaimer:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event.

Technical requirements:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save time, you can setup prior to the meeting by following this link:

https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php

Who Should Attend:
Psychologists, Social Workers, Licensed Professional Counselors, Marriage and Family Therapists, School Psychologists, Guidance Counselors, Psychiatric Nurses, Nurses, Psychiatric Nurse Practitioners, Case Managers, Alcoholism and Drug Abuse Counselors/Addiction Professionals, Pharmacists, Physicians, Psychiatrists, Mental Health Administrators, Special Education Teachers, College Counselors, Clergy, School Administrators

The Current Economy and What Does it Mean to You as an Investor in Real Estate and Notes

Mon, 14 May 2012 16:14:46 -0700

Start: 05/24/2012 - 13:00

End: 05/24/2012 - 13:00

Leading real estate consultant Christina Suter, owner of Ground Level Consulting in Pasadena, CA, co-hosts a FREE one-hour educational webinar with MOR Financial at 1:00PM Pacific Time on May 24. She will discuss the current domestic and global economy, how it affects real estate portfolios, what investments make sense at this time, and when to buy. Sean Morsi and Ajay Mehra of MOR Financial will address asset-based lending, notes and trust deeds for real estate cash flow without direct property ownership.

Topics include:

• Where the US and International economy is now.
• Are we still in a recession?
• Why should we care as real estate investors?
• How does this affect investment decisions?
• When is it a good time to buy?
• What should I be buying?
• Cash flow through real estate without owning a single property!

As the founder and lead consultant of Ground Level Consulting, Christina Suter brings two decades of real-world experience as a serial small business owner and real estate investor. She developed her extensive financial and operational skills firsthand as she faced and overcame each difficulty that appeared along the way. As a result, Christina has started up, managed and sold several businesses successfully, while developing an extensive real estate portfolio. Learn more at www.groundlevel-consulting.com

Specializing in trust deed investments, MOR Financial helps investors generate passive monthly income using real estate without owning a single property. Join us on the webinar to learn more about notes, trust deeds and how to protect your assets. To learn more about MOR, please visit www.mor-capital.com | www.morfinancial.com

Please note: Correct time is at 1:00PM in the afternoon PDT (site glitch stuck on AM).

Free Webinar: Developing Student Success Through College Readiness

Wed, 16 May 2012 19:15:34 -0700

Start: 05/24/2012 - 13:00

End: 05/24/2012 - 13:00

The Learning House, Inc., an online education solutions partner that helps colleges and universities develop and grow high-quality online degree programs and courses, will host a free webinar titled “Developing Student Success Through College Readiness” on Thursday, May 24, at 1 p.m. EDT.

During the webinar, Victoria Alexander, Vice President of Curriculum Development, and Elizabeth Dalton, Manager of Digital Curriculum, will outline several variables to consider when designing a developmental education program, including:
• Financial aid eligibility
• Course credit availability
• Timing of courses (parallel vs. front-end)
• Student support requirements
• Cost containment
• Curriculum design

The webinar will also discuss using technology and online developmental education classes to enable student success.

To register for the webinar, please visit: http://www.learninghouse.com/resources/webinars/developing-student-success

Tips and Tricks to Stay Out of the Spam Folder

Mon, 14 May 2012 09:05:59 -0700

Start: 05/29/2012 - 13:00

End: 05/29/2012 - 13:00

Staying out of the spam folder is tougher than you might think. Over 20% of legitimate email never makes it to the inbox. Customers quickly become frustrated when they don’t receive important messages like password resets, purchase confirmations and shipping notifications. Join email experts Carly Brantz and Elmer Thomas on May 29th at 1:00 PM EDT as they break down ways to make sure your email stays out of the spam folder.

This webinar will cover:

•CAN-SPAM Act Compliance

•Spam trigger words

•Importance of text-only versions

•How to authenticate your email

21 CFR Part 11 compliance for Electronic Medical Records

Fri, 27 Apr 2012 04:12:08 -0700

Start: 05/30/2012 - 10:00

End: 05/30/2012 - 11:00

This 21 CFR Part 11 training will analyze the regulations and provides concrete guidance on compliance for Electronic Medical Records.

Description:

Electronic Medical Records are the future. Some facilities and doctors are already using this cutting edge technology, and the medical community in general is moving in this direction.

FDA regulations governing electronic records and electronic signatures will be enforced upon these systems as they are used and become more prevalent. This presentation analyzes the regulations and provides concrete guidance on compliance.

Areas Covered in the seminar:

Review of current status of 21 CFR Part 11.
What is the relationship between "validation" and "part 11 compliance" to electronic medical records?
What do I have to do today to be in compliance?
What changes can I expect to see in Part 11?
When will I need to be in compliance?
What is the future part 11 likely to look like?
How can I best integrate part 11 compliance into my quality system?
How can I ensure what I do today will stand inspection tomorrow?

HIPAA Breach Notification - Webinar By ComplianceOnline

Mon, 30 Apr 2012 00:21:23 -0700

Start: 05/30/2012 - 10:00

End: 05/30/2012 - 11:30

This 90-minute webinar on HIPAA Breach Notification will show how to create an effective breach notification policy for your organization and how to follow through when a breach occurs. You will learn about the kinds of threats that exist for PHI, information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well.

Why Should You Attend:

The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations.

The presentation will cover what goes into an effective breach notification policy, how to prevent breaches as much as reasonably possible and what steps to take when a security incident or breach has occurred. We will cover the essentials of information security methods you can use to keep breaches from happening, and be in compliance with the HIPAA Security Rule as well. We'll also discuss the new penalties for non compliance, including mandatory penalties for "willful neglect" that begin at $10,000.

Learning Objectives:

Learn about the HIPAA Breach Notification Rule
Find out what is a breach
What to do to prevent a Breach
What to do to prepare for a Breach
How to avoid Breach Notification
What are the most common types of breaches you can avoid

Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

Thu, 12 Apr 2012 10:13:23 -0700

Start: 05/30/2012 - 10:00

End: 05/30/2012 - 11:00

Many sponsors and CROs rely on an IT infrastructure that includes multiple disconnected safety and pharmacovigilance systems that vary by region and vendor. Although merging these systems into a single global solution may seem daunting and provide you with many technical challenges, it could be a crucial goal on the horizon for your organization.

Please join BioPharm Systems' Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar in which he will review a recent project for a top pharmaceutical company that entailed the merging of multiple drug safety systems into one global Argus Safety pharmacovigilance system.

Specific topics that will be examined include:

-Adverse Event Case Migration
-Merging and Configuring
-Data Cleansing and Consistency
-Configuring Reporting Rules

Wednesday, May 30, 2012 @:

7:00 a.m. US Pacific time
8:00 a.m. US Mountain time
9:00 a.m. US Central time
10:00 a.m. US Eastern time
15:00 UK time
16:00 Central European time

How to Sell Your Idea

Wed, 16 May 2012 12:28:14 -0700

Start: 05/31/2012 - 09:00

End: 05/31/2012 - 10:00

Price Associates is once again excited to host a complimentary webinar featuring Justin Foster, Brand Strategist and www.SlideKlowd.com co-founder. Justin will be speaking on the 5 "must haves" for selling your idea.

Whether you are a start-up selling your idea to VCs or are an established brand introducing a new product / service to the marketplace, you will learn:

~ 3 reasons why ideas die
~ How demographic data can be misleading
~ Why doctors get paid more than janitors
~ How the future of your idea may depend on a 10-second span
~ Why pictures and words are rocket fuel for ideas

This webinar is open to anyone who's livelihood depends on the ability to sell an idea: Executives, business owners, consultants, and marketing and sales teams. Feel free to share the webinar link with anyone that you think would benefit from attending.

Title: How to Sell Your Idea
Date: Thursday, May 31, 2012
Time: 9:00 AM - 10:00 AM MDT

Reserve your Webinar seat now at:
https://www3.gotomeeting.com/register/324837894

GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics - Webinar By ComplianceOnline

Sun, 29 Apr 2012 23:29:33 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 11:00

Why Should You Attend:

In this Webinar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This presentation will define the terms and their application in the development environment.

During product development within an organization that has yet to commercialize a product, the use of the terms GLP and GMP are often confused and may be used incorrectly. Doing so can result in reducing credibility by regulatory health authorities, as well as cause confusion when working with collaborators. The objective of this seminar is to define the terms, what they mean and how they are applied.

Areas Covered in the Seminar:

Nomenclature.
How the GLPs and GMPs came to be an their evolution.
The major sections of GMPs.
The major sections of GLPs.
A comparison of the two.

Risk-Based Validation Equipment Validation - Webinar By ComplianceOnline

Tue, 27 Mar 2012 04:07:55 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 11:30

This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.

Why Should You Attend:

In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality.

This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. It includes a specific real-life project involving over 100 separate pieces of equipment and utilities, and the regulatory inspector's subsequent comments.

This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master plan.

How do I Keep FDA Happy with my Contract Manufacturer-Webinar By ComplianceOnline

Sun, 29 Apr 2012 22:06:01 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 11:00

This webinar will cover techniques and process that can help you assure reliability and consistent quality from your suppliers or contract manufacturers. You will learn how to monitor your supplier and ensure they meet FDA's quality requirements.

Why Should You Attend:

No matter where a product is manufactured, quality is the responsibility of the organization whose name appears on the label. If you hire a contract manufacturer to make products that will carry your label and your name, the responsibility for the quality of that product is yours. There are many things that you can do to assure quality and these quality assurance procedures will be covered in this webinar. It should not be necessary to do all of the things that will be discussed - - the secret is to create a system that fits your products, your contractor and your needs. In fact, the quality assurance process may change over time as you learn more about the contract manufacturer you are using and the contractor's commitment to quality.

Areas Covered in the Seminar:

Selection of a Contract Manufacturer.
Auditing your Contract Manufacturer.
Contractor's quality procedures.
Contractor's analysis of raw materials, in-process, and finished products.
Packaging & Shipping.

Documentation and Record Keeping: Establishment, Maintenance, and Availability of Records Related to Food Safety - Webinar By ComplianceOnline

Mon, 30 Apr 2012 00:04:17 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 11:00

This webinar on documentation and record keeping related to food safety will cover FDA requirements regarding establishment and maintenance of records related to food safety help you make sure you fulfill the FDA's expectations.

Why Should You Attend:

Food manufacturers, processors, packers, distributors, handlers, transporters and importers need to become aware of and begin implementation of new food safety record keeping requirements. While the FDA may not have yet clearly stated and established food traceability requirements, they have clearly established record keeping and documentation requirements that allow them to require traceability of all food handling processes and transportation. By citing customs and border protection needs under homeland security needs, the FDA is now empowered to require and inspect food handling and safety documentation for virtually all phases of food production. In order to prove that you are working to prevent food safety problems and outbreaks, you had better have a sophisticated and well managed documentation system. Failure to do so can cost you $244 per hour in federal inspection costs and will cause shipments to stop in their tracks.

This webinar will cover what is required and will help you make sure you fulfill the FDA's expectations. We will discuss requirements that the FDA might establish regarding establishment and maintenance of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that are required to be kept by these regulations are those needed by FDA for inspection to allow FDA to identify the immediate previous sources and immediate subsequent recipients of food.

Areas Covered in the Seminar:

Establishing a documentation system: Policy, Procedures, Records
Check sheets, records, sign-in sheets
Food Safety documentation (Forms)
Organic farm documentation (Paper and Electronic Forms)
Real-Time Electronic data systems

What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?-Webinar By ComplianceOnline

Fri, 27 Apr 2012 04:54:56 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 11:00

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

Why Should You Attend:

Significant audit/inspection findings expose you and your organization to regulatory or contractual sanctions, including but not limited to – discontinuation, disqualification, seizure, injunction and/or civil money penalties.

Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure your organization’s readiness for an audit/inspection at all times.

This training will teach you how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. We will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how to ensure the conduct of the clinical research at the investigative site(s) complies with them. By attending this training you will be able to appropriately act upon the audit or inspection findings – to correct current misconduct and prevent future recurrence.

Learning Objectives:

Understand what Audits/Inspections are all about.
Obtain tools and techniques for a planned Audit/Inspection preparation.
Learn the DOs and DON'Ts prior to and during an Audit or Inspection.
Understand what actions are required following an Audit/Inspection.
Obtain tools and techniques to ensure Audit/Inspection preparedness is maintained at all times.

Social Media Policies and Guidelines - How to be Compliant, Yet Creative and Successful on Social Media Sites - Webinar By ComplianceOnline

Mon, 30 Apr 2012 01:09:51 -0700

Start: 05/31/2012 - 10:00

End: 05/31/2012 - 14:00

This 4-hr virtual session on social media policies will help you navigate the complexity of how to develop a social media policy that is in compliance with your Legal, Compliance, and HR Department.

Why Should You Attend:

This workshop will teach you the protocol for engagement on each social network, namely, Facebook, Twitter, Google+, and Pinterest. At the end of this workshop you will be able to develop guidelines for employee usage, and learn how to leverage social networks to increase your visibility among top candidates. You will also learn how to establish your company as an employer of choice. In addition, you will learn how to engage, and be successful on social networks. It all begins with a strong, and efficacious social media policy.

This session discusses your reasons and rights as an employer to establish guidelines for social media usage for optical outcomes. It also educates HR Professionals on how to levy consequences that is in compliance with HR Law. We will cover case studies of employees who have been fired due to their negative social media behavior, we will look at cases that were won in favor of the company, and cases where employees have sued companies for being fired where the employee won.

Areas Covered in the Seminar:

What is a social media policy?
Your rights as an employer to establish a social media policy and guidelines.
What to include in your social media policy.
Define the guidelines of each social network, its culture, and success factors, and best practices.
Professionalism: how to interact, engage vs broadcasting automated messages.
Introduce tools that can manage your social media monitoring.
When does dress make a positive or negative impact on performance?

Device Corrections and Removals - Webinar By ComplianceOnline

Tue, 27 Mar 2012 03:17:53 -0700

Start: 06/01/2012 - 08:00

End: 06/01/2012 - 09:30

This 90-minute webinar on device corrections and removals will clarify your obligations for corrections and removals under Part 806 of the FDA regulations.

Why Should You Attend:

When your firm finds a problem with a device you shipped and fixes it, do you report it to the FDA?

If you send a letter to a customer that says, “We found a problem, but, not to worry, we will fix it for you!”, you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision.

An FDA Inspection will check for Corrections and Removals since it is part of QSIT. Often Inspectors will check specific actions, since they will monitor your website and have copies of letters you sent to customers. If you send a letter that notifies your customers of a problem, it will almost certainly get to a competitor who will send a copy to FDA. If you didn’t report to FDA, the Inspector will ask for your records documenting the reason not to report. This webinar will clarify your obligations for corrections and Removal under Part 806.

Understanding Inattentive ADHD: Recent Updates in Evidence-Based Screening and Treatment Strategies

Thu, 17 May 2012 10:56:40 -0700

Start: 06/01/2012 - 14:00

End: 06/01/2012 - 14:00

Discover why Inattentive ADHD is different from other types of ADHD and learn the latest information about screening, SCT, symptomatology, comorbidities, treatment modalities, medication, and how this disorder may be mentioned in DSM-5.

Full Description:
Why is Inattentive ADHD Different? New Information
Attention-Deficit Hyperactivity Disorder, Predominately Inattentive Type is NOT a “calmer” or “lighter” version of ADHD. The neurophysiology, symptoms, treatment methods, and medications for this disorder are different than the other types of ADHD. Since patients with Inattentive ADHD are not typically as disruptive as those with other types of ADHD, this type is commonly misunderstood or goes unrealized by the mental health professional. Little research has been done compared to Combined ADHD and most seminars and webinars only spend a small portion of time on Inattentive ADHD.

This one-hour course will provide participants with the latest information about screening, Sluggish Cognitive Tempo (SCT), symptomatology, comorbidities, treatment modalities, medication, and how Inattentive ADHD may be mentioned in DSM-5.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Identify the differences between Attention-Deficit/Hyperactivity Disorder, Predominately Inattentive Type (Inattentive ADHD), and other forms of ADHD
Define treatment methods for Inattentive ADHD and how such methods are different than those for other forms of ADHD
Outline the common co-morbidities of Inattentive ADHD
Evaluate new research about Sluggish Cognitive Tempo and its relationship to ADHD
Discuss how Inattentive ADHD may be described in DSM-5

Who Should Attend:
Psychologists, Social Workers, Licensed Professional Counselors, Marriage and Family Therapists, School Psychologists, Guidance Counselors, Psychiatric Nurses, Nurses, Psychiatric Nurse Practitioners, Case Managers, Alcoholism and Drug Abuse Counselors/Addiction Professionals, Clergy, School Administrators, Physicians, Psychiatrists, Mental Health Administrators, Special Education Teachers, College Counselors

ICH Q10; moving from GMPs to a Pharmaceutical Quality System - Webinar By ComplianceOnline

Tue, 27 Mar 2012 03:49:22 -0700

Start: 06/05/2012 - 10:00

End: 06/05/2012 - 11:30

This ICH Q10 training /webinar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10.

Why should you Attend:

Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to Quality Systems in the pharmaceutical industry. This seminar will discuss the transition in the FDA oversight from a strict audit against the regulations as defined in the GMPs to a review of the high level quality system and the involvement of senior management in compliance to the GMPs.

The discussion will begin with the establishment of ICH and its original purpose to facilitate registrations throughout the world and discuss the impact of Quality systems such as ISO 9000 and the medical device GMPs. It will continue with the effort of the agency to change the way it regulates and the impact of the international focus on Quality Systems and how ICH broadened its scope and responded to the international move to a quality systems approach.

Childhood Peer Aggression and Victimization

Thu, 17 May 2012 10:51:59 -0700

Start: 06/05/2012 - 14:00

End: 06/05/2012 - 14:00

This one-hour webinar will introduce attendees to the interpersonal dynamics of childhood peer aggression and interventions for victims and aggressors. Current research on treatment and prevention will also be discussed.

Full Description:
The Interpersonal Dynamics of Bullying
This webinar will provide an understanding of the interpersonal dynamics of childhood peer aggression, also referred to as bullying. Understanding the fundamental elements of this unique relationship will help attendees distinguish bullying from usual peer conflicts. The short and long-term effects of victimization will be reviewed including the “bully victim” who often normalizes antisocial behavior. We will discuss interventions for victims and aggressors and cover recent research suggesting that structural family therapy and solution-focused family therapy are effective at reducing the abusive behavior of aggressors as well as assisting victims. In cases where family therapy is not an option, viable alternatives (individual and group cognitive therapy) are also reviewed. Additionally, recent research on prevention will be included.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Discuss the unique interpersonal dynamics of childhood peer aggression and victimization
Define the personality and behavioral traits of children who are aggressive toward peers
Assess the impact of childhood peer aggression on the victim
Discuss basic theory and practice of structural family therapy, solution-focused family therapy, and cognitive therapy for aggressors and victims
Examine the results of the research on effective prevention of childhood peer aggression

Your Presenter:
THOM MOTE, M.Ed., LPC, is a privately practicing counselor in Northwest Georgia and Chattanooga, Tennessee. His 16 years of counseling experience include specializing in adjustment therapy, life transitions, and grief counseling with individuals, couples, and families. He has presented numerous workshops to live and television audiences on topics such as abusive youth, structured parenting, positive psychology, and compassion fatigue.

Who Should Attend:
Social Workers, Psychologists, Counselors, Play Therapists, Juvenile Justice Personnel, Nurses, Psychiatric Nurses, Nurse Practitioners, Educators, Marriage and Family Therapists, Alcohol and Drug Abuse Counselors,Parents

Pharmacology of Antidepressant Drugs

Thu, 17 May 2012 11:00:43 -0700

Start: 06/06/2012 - 11:00

End: 06/06/2012 - 11:00

Discover multiple classes of antidepressants and how they are used inside and outside of treating depression.

Full Description:
This one hour webinar will introduce participants to the various classes of antidepressant drugs, arranged according to the dates of their introduction into medicine. General uses, side effects, effects in pregnancy, and uses outside of treating depression will be emphasized within each category. Having knowledge of the side effects will allow the non- prescriber to monitor for adverse effects that may limit a patient's daily functioning. We will also discuss withdrawal and overdose syndromes where applicable. Finally, we will explore the STAR-D study results to attain a detailed description of the efficacy of these drugs to relieve depression.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Discuss the uses of antidepressants as antidepressants, anxiolytics, and analgesics
Identify the mechanisms through which these drugs relieve depression, including references for further self-study
Examine the limitations of tricyclic antidepressants and the side effects to watch for in clinical practice
Discover what SSRI means, the different serotonin receptors, and common side effects of use as well as withdrawal distress (including serotonin withdrawal syndrome in the neonate)
Understand why dopaminergic agonist antidepressants can cause, rather than relieve, anxiety

Your Presenter:
Robert M. Julien, MD, PhD, is both an anesthesiologist and psychopharmacologist with over 40 years of experience. He received his PhD from the University of Washington in 1970 and his MD from the University of California at Irvine in 1977. Previously an Associate Professor of Pharmacology and Anesthesiology at the Oregon Health Sciences University, Dr. Julien lectures widely on psychopharmacology. With over 36 years of continuous publication, Dr. Julien's psychopharmacology textbook, A Primer of Drug Action (Worth Publishers), is regarded as the definitive textbook of psychopharmacology, covering both psychotherapeutic agents as well as substances of abuse. Dr. Julien is a nationally recognized speaker and expert in psychopharmacology.

Who Should Attend:
Pharmacists, Psychologists, Social Workers, Counselors, Drug and Alcohol Counselors, Marriage and Family Therapists, Case Managers, Nurse Practitioners

Designing Effective and Efficient Extractables/Leachables Studies for Biologics - Webinar By ComplianceOnline

Fri, 27 Apr 2012 05:11:33 -0700

Start: 06/07/2012 - 07:00

End: 06/07/2012 - 08:30

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

Why Should You Attend:

The FDA industry guidance for container-closure systems for packaging human drugs and biologics requires the testing of container closure components for extractable leachable for all injectibles. Since biologics products are particularly sensitive to leachable there has been increased scrutiny of extractable and leachable associated with biotechnology drug products. The time and resources required for testing for extractable/leachable can be conserved by appropriately planning the study.

This interactive webinar will provide an overview of the steps in a typical Extractables/Leachables study. The literature sources which can preliminary information essential for the plan of a E/L study will be discussed. Gap analysis of such literature leading to the design of an efficient E/L study will be addressed. Steps in an E/L study, handling the data and cases studies will be presented.

Areas Covered in the Seminar:

Why test for Extractables Leachables.
Challenges presented by E/L studies for Biologics.
Sources of E/L information and how to leverage them.
Testing for Extractables.
Testing for Leachables.
Interpretation of the E/L data.

Making All Data Count: FDA Acceptance of non-US Clinical Trials - Webinar By ComplianceOnline

Fri, 27 Apr 2012 05:37:40 -0700

Start: 06/07/2012 - 08:00

End: 06/07/2012 - 09:00

This webinar will help you understand how non-IND clinical trials at non-US locations can be used successfully to support an IND/IDE or a marketing approval application. It will cover the critical product specific issues (drugs, biologics, diagnostic kits and medical devices) that need to be addressed when using non-US data for discussions with FDA.

Description :
FDA acceptance criteria for non-IND/IDE clinical trials are based on internationally recognized standards of quality, ethics, and practices for human subject protection. An adequately designed non-US study can be used to greatly reduce the time of cost of getting the tested product to the US market.

If you have conducted non-IND clinical trials at non-US locations or if you would like to understand how non-IND trials can be used successfully to support an IND/IDE or a marketing approval application, this seminar is a must for you. The speaker will share his extensive experience in multi-national IND and non-IND studies to underscore the critical issues that need to be addressed when using non-US data for discussions with FDA. Case studies from drugs, biologics, diagnostic kits and medical devices will be used to highlight product specific issues with non-US clinical trials.

Areas Covered:

Comparison of US and non-US regulatory requirements for clinical trials
Parameters of quality of clinical trials: investigators and sites
Acceptable design of non-US clinical trials
FDA’s opinion of non-US regulatory review and approval of clinical trials

Navigating the Japan and South Korean Regulatory Compliance and Clinical Trial Environment

Mon, 07 May 2012 03:21:28 -0700

Start: 06/07/2012 - 09:00

End: 06/08/2012 - 16:00

Course Description:

This 2-day on-site Course will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan and South Korea. It will prepare you for the regulatory approval processes, Agency meetings, the complexities of running studies in both countries, the importance of partner selection and the cultural knowledge needed for success. The recent changes made by PMDA and KFDA to be more sponsor-friendly will be reviewed. Real world experiences on actual interactions with the Agencies since these changes, will also be discussed.

Who will Benefit:

This course will be beneficial to the following personnel whose responsibilities require knowledge of Japan and South Korea's regulatory requirements for Life Science products:

Regulatory Compliance personnel
Clinical / Pharma & Device personnel
Clinical Trial Project Managers
Monitors / CRAs
QA / QC Personnel
Pharmacovigilance reporting personnel

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment

Thu, 29 Mar 2012 03:29:49 -0700

Start: 06/07/2012 - 10:00

End: 06/07/2012 - 11:00

This Clinical Laboratory Improvement Amendments (CLIA) training will be valuable to CLIA regulated non-waived laboratories that run automated analyzers or semi-quantitative kit tests.

Why Should You Attend:

All non-waived laboratories must have a QC and QA plan that meets CLIAs’s regulations. CLIA (Clinical Laboratory Improvement Amendments) has updated its requirements for QC and QA. CLIA has replaced the term Quality Assurance with the term Quality Assessment. The new guidelines regarding QA specifically stress measuring quality through all aspects of the testing process. This includes pre-analytical, analytical, and post-analytical parts of the process as a whole. QA is now focused on measuring outcomes and developing actions based on findings. The Quality Control process has guidelines in place for all three levels of testing; Waived, Moderately Complex and High Complexity.

Attend this webinar to understand the differences and the proper methods to meet the guidelines. It is important to understand that measuring quality is essential to assessing quality. The measurement of processes and the outcomes is the only way to truly assess quality.

Integrating Art Therapy into Your Professional Practice

Thu, 17 May 2012 11:52:55 -0700

Start: 06/07/2012 - 14:00

End: 06/07/2012 - 14:00

This one-hour webinar provides attendees with a definition of art therapy, its benefits, & how it differs from verbal therapy. Case studies will

be presented to assist attendees in identifying indicators & key images in their clients’ art.

Full Description:
This webinar program provides definitions of what Art Therapy is and how it differs from verbal therapy. The role of art-making in diagnosis and

treatment is addressed through assessment by examining age-appropriate drawing skills and the symbolism of images that have personal meaning to

our clients. In addition, this course examines art-making as personal growth and its therapeutic benefits. The attendees will learn specific

indicators to look for in their clients’ art work and how to identify key images through the presentation of several case studies. Through these

case studies the participants will identify how clients can express their mood through drawing and painting. Psychological and behavioral

problems, such as regression and impairments, will be identified through the symbolism in clients’ art work.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
1.Discover a new method of communicating with clients
2.Examine effective Art Therapy techniques
3.Understand the therapeutic power that art provides
4.Acquire skills for assessing the client’s stress level
5.Discuss current research as it relates to Art Therapy and its effectiveness with clients

Your Presenter:
Pamela M. Hayes, MFT, LMHC, ATR-BC, is an artist and a registered and board certified Art Therapist. She is licensed as a Marriage and Family

Therapist and Mental Health Counselor and is currently in private practice in Los Angeles, California. Ms. Hayes developed the art therapy

program at the Rhode Island School of Design. For the past 15 years, Ms. Hayes has worked in numerous psychiatric settings. Currently, her focus

includes families, couples, adults, and children struggling with mood and anxiety disorders, addiction, eating disorders, abuse, and grief-

related issues. Ms. Hayes has an undergraduate degree in Fine Arts from Parsons School of Design in New York City and a graduate degree in

Marriage and Family Therapy and Art Therapy from Notre Dame de Namur University in Belmont, California. For more information about Ms. Hayes,

please visit her website at: www.hayesarttherapy.com

Disclaimer:
This event qualifies for one CE credit. Only registered attendees will have access to CE. A Cross Country Education web account is required to

attend. There is no charge for a CCE web account. It is recommended that you join the meeting 15 to 20 minutes early. Speaker phone sound

quality is poor and it is recommended that they not be used to listen to the event.

Technical requirements:
To view this webinar you will need to download the WebEx Application. You will be prompted to download it when you first enter the site. To save

time, you can setup prior to the meeting by following this link: https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php

Who Should Attend:
Marriage and Family Therapists, Licensed Professional Counselors, Social Workers, Psychiatric Nurses, Drug and Alcohol Abuse Counselors,

Pediatricians, Physicians, Art Therapists, Pastoral Counselors, Guidance Counselors, Youth Pastors, Youth Counselors, Educators

Eliminate the Confusion – Analytical Method Qualification and Validation - Webinar By ComplianceOnline

Fri, 27 Apr 2012 05:19:33 -0700

Start: 06/08/2012 - 10:00

End: 06/08/2012 - 11:00

This webinar will help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle.

Why Should You Attend:

Execution of a method validation is a resource intensive activity, both in terms of manpower, equipment usage, time, and money. The more the process is well defined and understood, the greater the potential for an efficient project. The less the process and its elements are understood, the greater the chance for delays and additional resource expenditures. There is confusion and a lack of guidance over what constitutes a method qualification compared to a method validation, and what are the requirements for different phases of validation, what is needed at each product phase (I,III,commercial), and what to do when there are failures within a validation. Inclusion of a CRO as an additional factor in this plan potentially escalates areas that need resolution-differences in quality systems, validation requirements, and reports to name a few. Communication without common definitions and understanding of the terms can lead to areas of confusion, project misdirection, and missed timelines.

Learning Objectives:
This training will enable the user to understand what is the difference in these terms - qualification and validation, how each term applies to the group of methods for which the user is responsible, and when each may be applicable. There are some essential elements of entry for a method for both qualification and validation- and these elements will be reviewed (development reports, qualification reports, ICH category defined for method…). In addition, there can be excursions of various types in qualification/validation activities-and potential ways to address these will be covered.

Areas Covered in the Seminar:

Definitions of Terms-qualification, validation, verification, co-validation, intended use.
Standards-Q2R1, FDA Guidelines.
Requirements for Entry-what is needed in order to start a qualification or validation.
Requirements for Execution.
Documentation needs-SOPs, Forms, Worksheets, Data Output, Protocols, Reports.

Treatment of Depression in Children and Adolescents

Thu, 17 May 2012 11:04:32 -0700

Start: 06/08/2012 - 11:00

End: 06/08/2012 - 11:00

Untreated depression in children and adolescents can lead to more serious episodes of depression during adulthood. Drug choice and length of treatment can make a significant difference is the lives of your youngest patients.

Full Description:
This one-hour webinar will introduce participants to the role of antidepressant drugs in treating depression in children and adolescents. During our time together, we will examine drug efficacy both with and without adjunctive therapies, including fluoxetine as the most effective medicine for this use. The issue of black box warnings and potential suicidality will be addressed as well as available alternative and adjunctive medications. Drug choice, length of initial trials, and withdrawal strategies will also be addressed. Finally, we will discuss the TORDIA study. Its results will enable a detailed account of augmentation strategies when fluoxetine therapy is found to be insufficient.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Examine the unique use of fluoxetine therapy in child and adolescent depression as well as its limitations
Define the origins of early age depression and the mechanisms involved
Recognize that preschool depression is a real phenomenon and not a developmentally transient disorder
Discuss the later life consequences of untreated depression in children and early-age adolescents
Identify why adjunctive medication therapy may be needed for resistant depression

Who Should Attend:
Pharmacists, Psychologists, Social Workers, Counselors, Drug and Alcohol Counselors, Marriage and Family Therapists, Case Managers, Nurse Practitioners

Oppositional Defiant Disorder in Young Children and Early Teens: A Three-Step Approach to Intervention

Tue, 13 Dec 2011 14:25:47 -0700

Start: 06/08/2012 - 13:00

End: 06/08/2012 - 13:00

Oppositional Defiant Disorder doesn’t have to be complicated! This web course provides mental health professionals with a three-step approach to treating the signs and symptoms of ODD and co-occurring disorders in children and teens,

ages 4-14.

Full Description:
Confronting Defiance
According to the AACAP, evidence suggests that between 1 and 16% of children and adolescents have Oppositional Defiant Disorder (ODD). Challenged by basic rules of society, this disorder causes a struggle between the parent and child and

ultimately the therapist and child. Tantrums, arguing, defiance, blaming, and anger when left untreated may disrupt classrooms, strain families, and lead to a risk of juvenile delinquency. Conflict may also go on to affect the

behavioral, academic, and social success of the child.
This webinar discusses ODD, similar disorders, and the effect on young children and teens. Using a three-step approach to intervention called SimpleThree, mental health professionals will learn how to treat ODD symptoms in children and

adolescents as well as educate parents to reinforce good behavior to maintain success.

Course Includes:
Live Q&A
Presentation Handout
Post session recording access
CE Credit

What You Will Learn:
Identify Oppositional Defiant Disorder, children at risk, and differentiate from similar childhood diagnoses by etiology and behavior
Apply a three-step, evidence-based approach to intervention called SimpleThree with defiant children ages 4-14
Incorporate a behavioral modification system using clear, measurable rules to encourage good behavior and structure
Learn how to strategically follow up with families to reinforce effective parenting skills and maintain success and support with easy-to-access resources

Your Presenter:
WARD HALVERSON, LCSW-R, M.Ed., is a licensed clinical social worker and educator with over 12 years of experience as well as a former school teacher, army veteran and medical officer, and father. He received a master’s degree in Social

Work from Syracuse University and a master’s degree in education from The College of Saint Rose. Mr. Halverson currently runs an outpatient mental health private practice where he specializes in the treatment of child and family

defiance, anxiety, and trauma, and has developed the SimpleThree system to approach these issues with his clients as well as other mental health professionals.

15 to 20 minutes early. Speaker phone sound quality is poor and it is recommended that they not be used to listen to the event.

https://apidemoeu.webex.com/apidemoeu/meetingcenter/mcsetup.php

Who Should Attend:
Social Workers, Psychiatric Nurses, School Nurses, Psychiatric Nurse Practitioners, Licensed Professional Counselors, Marriage and Family Therapists, Psychologists, Educators, School Social Workers, School Administrators, Foster Care

Professionals, Parents, Clergy

How To Establish An Effective Good Clinical Practice in Drugs and Medical Devices - Webinar By ComplianceOnline

Fri, 27 Apr 2012 05:44:25 -0700

Start: 06/11/2012 - 10:00

End: 06/11/2012 - 11:30

This 90-minute webinar will help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner.

Why Should You Attend:
To be able to achieve sustainability and to remain sustainable and competitive in global medical product markets, it is necessary to streamline regulatory compliance processes, in particular, the Good Clinical Practice (GCP) for clinical trials and studies and beyond. To establish and maintain GCP, it is critical to accurately define, document and implement “current, accurate, and complete” (CAC) requirements pursuant to the relevant and applicable laws and regulations, GCP requirements, and compliance in a systematic, integrative (SI) manner.

This webinar is intended to help you establish an effective Good Clinical Practice (GCP) by providing a current, accurate and complete (CAC) review and understanding of the relevant and applicable regulations for clinical trials or studies, the requirements and compliance in a systematic, integrative (SI) manner, all of which are regulated by the United States Food and Drug Administration (FDA). At the end of this webinar, you will leave empowered with the knowledge of applicable FDA regulations and requirements.

Areas Covered in the Seminar:

Current, accurate, and complete (CAC) review of FDA regulations including INDs and IDEs.
Systematic and integrative (SI) analysis of regulations and law governing clinical trials and studies, requirements, and compliance.
General information for clinical studies.
Sponsors.
Contract research organizations (CROs)

FDA Warning Letter Closeout Program - Webinar By ComplianceOnline

Mon, 26 Mar 2012 22:55:23 -0700

Start: 06/12/2012 - 10:00

End: 06/12/2012 - 11:00

This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

Why Should You Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new FDA" is the increased issuance of warning letters and the creation of a warning letter "closeout", which regulated firms can use to your advantage.

FDA's warning letter program has changed substantially and more warning letters will be issued - and faster! In the past, firms that received a warning letter from FDA were subject to unending scrutiny, speculation and financial challenge. But now warning letter recipients will have the chance to prove they are back in compliance. , FDA will provide a manner for a firm to demonstrate that it has complied with the terms of an enforcement action. The warning letter closeout program has begun as of September 2009. All firms who receive a warning letter will have the opportunity to obtain a "closeout" letter from FDA. Firms that fail to obtain a closeout letter will be clearly identified as still being under FDA scrutiny.

Attend this Webinar to know everything about warning letters, warning signs, issuance, company’s response and how to rectify the FDA warning letter close out mistakes.

Integrating Art Therapy into Your Professional Practice

Thu, 17 May 2012 11:54:43 -0700

Start: 06/12/2012 - 14:00

End: 06/12/2012 - 14:00