Who: Param Singh, vice president of clinical trial management solutions, BioPharm Systems

Adrian Hampshire, managing director, EMEA, BioPharm Systems

Paul Dobrowolskyj, senior consultant, Oracle Health Sciences

What: Webinar: "Business and Operational Risks in Clinical and Safety: Applying Appropriate Technology and Approaches to Mitigate Risk"

All business processes are subject to some level of risk. Key to the long term viability of any company is the critical need to identify the risks, quantify them, minimize them, and have a clear plan for dealing with any residual risks.

Organizations try to mitigate risks by implementing systems that support the company's business processes. Commercial software systems that are available from vendors such as Oracle include many capabilities which, if implemented properly, greatly reduce the risks in the business process.

The implementation of complex systems is, in itself, a risky process. Organizations like BioPharm Systems have been able to use their wide range of experience to develop pre-configured and pre-validated solutions that help reduce the risks during the implementation of a clinical trial management system (CTMS) and a safety system.

This one and a half-hour webinar will provide an overview of business risks related to clinical and safety systems and will illustrate how the risks inherent in implementing complex CTMS and safety systems can be significantly reduced.

When: Thursday, November 17, 2011 @:

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

Webinar Information: To register for this complimentary webinar, go to: https://cc.readytalk.com/r/bf2hph6dutcu

Summary
Short and quick overview of the Part 11 regulation; detailed description of HOW TO prepare for an FDA inspection when and where Part 11 is in scope or the scope of the inspection; detailed description of HOW TO handle the FDA inspection during the inspection itself; some trends when it comes to Part 11 inspections; commonly asked questions; warnning letters examples; and what the future holds when it comes to Part 11.

Details
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15

Related Technical Document : Attendees will receive 30+ commonly asked questions; 21 CFR Part 11 regulation; Sample internal/external audit/inspection checklist based on 21 CFR Part 11 regulation

Why should you attend : More and more organizations are striving to "go green" and develop "sustainable" organization's strategies, which almost always includes using more and more of the computer technologies. Part 11 is a regulation that regulates the technology when it comes to electronic signatures and electronic records and will be more then ever a part of the scope of the FDA inspections, yet most organization do not know how to best prepare for such inspections.

In a time of global economy when and where time is of essence, having an ability to access records from any location around the world is more critical then ever, and for the same reason, electronic records will be more needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation.

Who will benefit :

Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants.
Instructor Profile : Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendace and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696

Summary
Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the "Why" and the "How". Although quite informal, this is a rudimentary CAPA system.

Details

Sometimes, no matter how well controlled, the input of the process fails to produce the expected output. A deviation or nonconformance has occurred. A deviation is defined as a departure from the expected input, in other words, a procedure was not followed, or a specification requirement was not met. A nonconformance, according to Part 820, means the non-fulfillment of a specified requirement. This requirement, like that of a deviation, indicates a procedure was not followed or a specification requirement was not met. When deviations/nonconformities occur, a system must be in place for evaluating the impact on quality, conducting an investigation to determine root cause, and following up to verify the root cause was properly identified .A Corrective and Preventative Action(CAPA) system must be in place to track these events until closeout of the event is completed.

Medical product problems require a stringent and formal CAPA system. The original GMP regulations for devices & drugs were embedded within the regulations. CAPA systems were first formalized for devices in the "Quality Systems Regulation" and for drugs in ICH Q-10, "Pharmaceutical Quality Systems"

The principles of handling deviations and nonconformities are the same for devices and drugs. For devices, the process is well outlined in the regulations. However, for drugs, the requirements are not so defined.

Why should you attend :

The FDA establishment inspection focuses on nonconformities/deviations and CAPA systems because deviations and nonconformities point toward quality system failures. You and your firm must be prepared. However, the need for a CAPA system is much more than a compliance requirement. Combined with investigations, it is one of the most useful tools for analyzing data leading to quality improvements and efficiencies.

This webinar will explore the Event-Investigation-CAPA (EIC) lifecycle and how you can apply it to your operations. This EIC lifecycle will be explained using graphics to explain regulatory requirements and industry practice, These graphics will serve as a model for establishing an effective and practical CAPA system.

By attending this webinar, you will better understand CAPA systems, learn ways to better use or improve your existing system, and begin development and implementation of a new CAPA system.

Areas Covered in the Session ( Objectives & Overview )

Good Manufacturing Practices And Quality Systems.
What do the GMP's Say About Deviations & Nonconformities and CAPA Systems?
The Importance of Master Records
Classifying Deviations and Nonconformities
Analyzing the Event (Deviation or Nonconformity)
Roles & responsibilities
The Deviation-Nonconformity and CAPA Lifecycle
Event
Discovery
Immediate Actions.
Notification of Event.
Establishing the Investigative Team (What function should take the lead?)
Data Collection.
Establishing the Root Cause
Preparing the Report and Conclusion
Approval of the Report
Close-Out & CAPA Entry
Tracking & Follow-Up.
Determining the Effectiveness.
The Next Step
Documentation and Record Keeping
What Will the Computer Do for You?
Review

Who will benefit :

Quality Control Laboratory Manager, Warehousing, Purchasing Managers and Procurement Managers, Laboratory Analyst, Cost Accounting, IT, Documentation Management

Instructor Profile : Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. He derives considerable satisfaction from diagnosing quality systems in order to make them more compliant, efficient, and productive. He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA. He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

Summary:

This webinar provides step by step instructions on how to design and manage a CAPA system that meets and exceeds compliance requirements.

Details:

Why should you attend - CAPA is the most audited Quality subsystem by the FDA.57% of all warning letters send to organizations by the FDA in 2010 were CAPA RELATED.The trend seems to be continuing this year.

Areas Covered in the Session

CAPA defined
The capa life cycle
CAPA requirements
CAPA design
CAPA documentation

Who will benefit: (Titles)

Quality managers
Quality Engineers
Process Engineers
Manufacturing Engineers

About the speaker:

Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.

Summary
This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, the regulations, and quality principles. The reduced testing lifecycle we studied and reviewed. This includes such topics as component specifications, material qualification, supplier auditing and qualification, collaborative laboratory testing, certificates of analysis, material validation sampling, analyzing testing, qualification, and disqualification. Examples of systems will be shown. This webinar will primarily use graphics, especially flowcharts, to demonstrate the principles and increase in understanding of the topics.

Details
Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.

The benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

As industry has been looking to reduce costs, improve efficiency, the FDA has begun to more closely scrutinize the industry’s effort to make certain that the above mentioned controls are in place. In this effort the FDA is focusing on supplier control and sampling issues.
Why should you attend :

Reasons for attending this webinar include the following:
To understand the compliance and quality requirements for reducing incoming material testing on pharmaceutical and medical device components.
To gain knowledge applicable to the control and qualification of suppliers that will increase compliance and improve efficiency
To reduce costs and increase efficiency in the handling of incoming materials and components.

Areas Covered in the Session:

Advantages and disadvantages of reduced testing
Basic review of quality systems.
Brief review of regulatory requirements.
Differences between suppliers and contractors.
Interdepartmental roles in establishing and maintaining a reduced testing program.
A study of the reduced testing lifecycle in graphical format , including specification control, material qualification, researching and selecting suppliers, supplier auditing (including selection of audit team members) and qualification, corrective actions, handling certificates of analysis, maintaining supplier quality and control, supplier change control, and handling problems suppliers.
Logistics of implementing a reduced testing plan

Who will benefit:

Quality Control
Laboratory Manager
Warehousing Purchasing Managers
Procurement Managers
Laboratory Analyst
Cost Accounting

About the speaker:

Howard enjoys sharing his 30 years plus experience in starting up, developing, implementing, managing, and remediating pharmaceutical and medical device quality systems. One of his favorite areas is material and supplier control from which he receives great satisfaction in applying his knowledge for improvement.
He has a BS in Biology/Chemistry and Political Science as well as work toward an MBA. His ability to quickly learn the technology is demonstrated by his success in applying quality assurance principles to a wide range of pharmaceuticals and medical devices. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Quality Auditor (CQA). His technical education is further complemented by his Political Science degree helping him understand the regulatory process; his work toward an MBA provides business insight. He is a member of ASQ, PDA, AAMI, RAPS, and SQA.
He strongly believes that Quality is very influential in shaping successful operations. He knows how to use his leadership abilities to build organizational relationships that make systems operate effectively as well as to develop and empower people.

Can the innate content management, collaboration and workflow features of SharePoint make it the next big technology platform for eProcurement & Purchasing?

Come join us for a free webinar and demonstration of Corevo a brand new platform for Procurement, Purchasing, Sourcing, Contracts and Commerce solutions built ground up on the SharePoint 2010 platform. You are able to manage complete procurement and purchasing processed with the flexibility and ease of use of a SharePoint platform with the Corevo solution that works on top of SharePoint.

Key Highlights of Corevo:

Pre-built Portal templates, workflow templates and features for most of the common procurement scenarios
More than 200 “out of the box” features
More than 50 “out of the box” web parts to integrate and implement in the solution
Modular and Business Process driven
Ability to extend forms, business logic, data sources, integrations
Extends SharePoint data, document and content framework with ease of SharePoint administration and management
Supports Active Directory Groups and User Security model
All solutions integrate “out of the box” with Vendor Extranet
On-Premises or Cloud options available for implementation
Continuous feature upgrades, improvements with a dedicated product team focused on improving the product
Maintenance & Support agreements allow customers to access our development and product engineering resources on-demand for all solution level issues

Please join us for a free educational webinar on the benefits of a SharePoint based eProcurement system, which outlines how SharePoint's document management, workflow and collaboration capabilities can bring in efficiencies in the procurement process.

Join us for this informative webinar by registering now!

International (Europe, Middle east & Africa) - Tuesday, June 1st 3 - 4 PM GMT
https://www1.gotomeeting.com/register/540588888

United States and Canada – Wednesday, June 2nd – 2 - 3 PM EST
https://www1.gotomeeting.com/register/410136545

"Trust Your Heart: Transform Your Ideas into Income" will inspire you to take your own dreams of owning a profitable business and turn them into reality.

Title: Trust Your Heart: Transform Your Ideas into Income
Series: The Story Behind The Story
Speaker: Marnie Pehrson
Panelists: Dr. Joseph Peck
Date: Tuesday, May 24, 2011
Start Time: 3 pm EDT (Eastern Time), Noon PDT, 9 pm U.K.
Duration: 60 minutes
Cost: Free

http://budurl.com/trustyourheart1

Marnie Pehrson is a best-selling author, speaker and online publicist who helps spiritually-minded entrepreneurs find their place in the world and deliver their messages online. She is the creator of the longest running content directory, IdeaMarketers.com, where you can promote your articles, press releases, information products, videos, audios and expertise. Marnie is also a wife and mother of 6 and the author of 20 fiction and nonfiction titles. If there's truth or talent to be highlighted, Marnie's your girl. Her mission is to help you live yours.

During this webinar, Marnie will share some amazing stories to encourage you to Trust Your Heart to Transform Your Ideas into Income. This includes:

- Her life story
- How IdeaMarketers.com was birthed, how that works, and some of the greatest fruit
- How "Trust Your Heart: Transform Your Ideas into Income" was birthed and how this ties into her mission to you live your mission

Marnie says, "You Have a Message! Let's Get It Out There!"

http://budurl.com/trustyourheart1

Each year marketing spends more of its budget to increase traffic. Yet conversion rates continue to hover around a dismal 3%. The fact is, conversion marketing solutions can dramatically improve conversion rates without relying on new traffic sources, because your most valuable traffic is the traffic you already have. Join us as we reveal the secrets of how the highest converting websites achieve conversion rates far above industry averages. In this free webinar, Forrester Research’s VP & Principal eBusiness Analyst Sucharita Mulpuru, will share with you her analysis and recommendations for the exciting new field of conversion marketing. TouchCommerce will show you actual examples of how we have helped drive $1.5B in incremental conversion lift for our customers. As we reveal 7 critical secrets of high converting websites, you will learn:
• Why now is the time to deploy conversion marketing solutions
• How much lift you can expect from the various conversion marketing solutions
• Optimal use of conversion marketing strategies throughout the customer lifecycle
• How to quickly implement conversion marketing and achieve revenue lift in 90 days

This webinar on California OSHA will provide basic training on the nuts and bolts of Cal/OSHA compliance requirements, its inspection procedures, and how to represent the employer during inspections and appeals of citations.

Description
Why Should You Attend:

For any business in California, knowing how to avoid a costly Cal/OSHA inspection or worse – civil or even criminal liability for a workplace accident – is essential.

California’s OSHA standards and enforcement program is unique compared to the federal OSHA and other state’s programs. Every employer in California must comply with Cal/OSHA standards, including its cutting-edge Injury & Illness Prevention Program, or I2P2 standard, and other requirements, which are more strict than their federal counterpart, even if there is one.

Cal/OSHA inspects employers of any size and aggressively responds to accidents involving serious injury. On average, Cal/OSHA penalties are over 300% more than federal, and the number of serious citations is increasing due to legislation that has changed, or “dumbed down” the definition of a serious violation. Personnel assigned by their employer to manage safety programs and OSHA affairs in California establishments face a significant challenge.

This webinar will provide basic training on the nuts and bolts of Cal/OSHA compliance requirements, its inspection procedures, and how to represent the employer during inspections and appeals of citations.

Areas Covered in the Seminar:

The following specific topics will be covered:

Postings, recording injuries and illnesses, and reporting fatalities and serious injuries.
Finding Cal/OSHA standards and determining applicability.
The most frequent violations as illustrated by photographs in a mock inspection context.
Knowing when you will be inspected and what to do to prepare.
How to handle the inspector and limit exposure to only the areas targeted for the inspection.
Handling employee interviews and document requests.
How citations appear, their classifications, and proposed penalties.
Defenses to citations, like employee unsafe act and employer lack of knowledge.
The appeals process – how to file an appeal, prepare for negotiations, and/or hearing.
Abatement of violations.
Other types of liabilities (Workers’ Compensation serious and willful claims, civil, and criminal), and how citations can lead to such liability.
Learning Objectives:

To train personnel assigned to manage safety programs on Cal/OSHA compliance and inspections on the basics of Cal/OSHA compliance and inspection management.

Handouts:

The webinar will include examples of forms, documents, photographs, and links to sources of standards and other inspection-related information.

Who Will Benefit:

Participants who will find this webinar particularly useful are

Senior Management
EH&S professionals
Plant/facility management
Operations personnel with responsibility for environmental compliance in California, or with multi-state responsibility that includes this state.
HR Managers.
For recent transfers to California in positions with environmental oversight or responsibilities, this webinar is a “must attend.”

The webinar is designed to be sufficiently basic that non-environmental professionals and lawyers, like managers, facility managers, and others assigned to handle environmental safety and health matters will benefit. Environmental professionals, consultants, and attorneys who practice in these areas will find nuances of California law and updates on recent changes in law/regulation useful.

Instructor Profile:

JAMES T. DUFOUR, MS, JD, CIH, REA is an attorney with a background in environmental management and industrial hygiene and workplace safety with more than 3 decades of experience, including private law practice since 1987 effectively representing clients in federal, California, and other state administrative, civil and criminal environmental cases. Recognized as a proficient strategist, his preventive and post-enforcement cost-effective compliance/clean-up plans have been highly regarded by clients, regulators, and judges. However, the emphasis of the practice is compliance assurance through cost-effective environmental management system design, audit programs, and educational programs. (www.dufourlegal.com)

Dufour has developed numerous environmental compliance reference manuals for trade associations and the California Chamber of Commerce.

James also has instructed thousands of participants in seminars and webinars sponsored by Dufour Seminars & Training, corporate and association clients, and webinar producers since 1986.(www.dufourseminars.com) New client inquiries are invited, including no obligation initial consultations.

Topic Background:

The federal Occupational Safety and Health Act of 1970 established the national framework for OSHA regulations and enforcement. It provided for federal standards and enforcement. It also provided for federal standards and enforcement, but authorized partly federally funded state OSHA programs that have to be at least as effective. About 20 states have state programs for private sector enforcement, and most of these follow federal OSHA standards and procedures. California is unique in that it has its own standards that can be quite different from their federal counterparts, enforcement procedures, and administrative penalties that are draconian compared to federal OSHA and other state enforcement, and onerous civil and criminal liability for OSHA standard violations.

Given the amount of penalties and other consequences of workplace accidents with injuries, employers are increasingly emphasizing accident prevention and OSHA compliance. As a result, personnel from plant and retail establishment management, human resources, facilities, line supervision, as well as safety personnel, are being assigned to safety and OSHA related work; in many cases, without formal training or experience in this area. This webinar, packed with useful compliance and inspection management information, will provide the basics, or “nuts and bolts” of Cal/OSHA.

For any business in California, knowing how to avoid a costly Cal/OSHA inspection or worse – civil or even criminal liability for a workplace accident – is essential.

An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. An OSHA inspection that goes badly essentially says the employer has a defective safety program, is not sufficiently focused on the safety and health of its employees, or is willfully or flagrantly exposing its workers to harm. What is worse is that the other liabilities beyond normal Workers’ Compensation costs can result from an OSHA citation related to a serious injury, including a Workers’ Compensation serious and willful claim, civil and even criminal liability. Federal OSHA under the new Administration has already established mandatory minimum penalties for serious violations and assessed 6- and 7-figure penalties pursuant to a ramped up egregious violation enforcement. Some states are following suit with California in the lead with $25,000 penalties for serious citations ($18,000 mandatory minimum if accident-related), and a “dumbed-down” defintion of a serious violation.

Please join me for this FREE 1-hour seminar and learn some of the best insider tricks to improve your "Google Juice." You'll get some easy ones and some hard ones, so there'll be something for everyone to use immediately to get more love from Google, and get found by customers online!

Register here: http://avarrasolutions.ilinc.com/register/vfxckkb