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« Thursday June 07, 2012 »
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Online Seminar Software

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

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

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.

Designing Effective and Efficient Extractables/Leachables Studies for Biologics - Webinar By ComplianceOnline
Start: 06/07/2012 7:00 am
End: 06/07/2012 8:30 am

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
Start: 06/07/2012 8:00 am
End: 06/07/2012 9:00 am

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
Start: 06/07/2012 9:00 am

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
Effective Corrective and Preventive Actions (CAPA): 10 Steps - Webinar By GlobalCompliancePanel
Start: 06/07/2012 10:00 am

Overview: This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verification & Validation of actions taken. Attend this webinar to grasp the A to Z of CAPA and learn how to implement & manage it for success.

Why Should You Attend: We have found out, through auditing many organizations world-wide that the organizations are pretty good when it comes to corrective actions yet they are not nearly as good when it comes to the preventive actions. This webinar should provide you with enough ideas, suggestions and HOW TOs that you and your teams and organization overall get much better on the preventive actions and even better on the corrective actions. Includes all elements of CAPA process step as required by ISO and regulatory agencies.

In addition, it is represented in a practical and proven manner which can be immediately applied in your organization.

Areas Covered in the Seminar:
Module 1
Introduction and Overview
Correction vs. Corrective Action
Understanding of all elements of CAPA process step as required by ISO and regulatory agencies
Introduction to CAPA elements in a practical and proven manner which can be immediately applied in your organization
Supporting stories and practical examples of CAPA - when each is appropriate and when one or the other is not appropriate
The regulations and international requirements for CAPA and the clear understanding how to suit your procedures, work instructions and forms to address it
Module 2
Examples of problem solving tools, management tools and measurement tools, which are great for identification of the true root cause(s) of the issue
These tools also used for corrective actions, for most optimal definition of the improvement, for preventive actions
Visual representation of the tools and examples where and when to use them
Importance of proper assignment of a CAPA
Examples are provided when it might be a good thing to assign a CAPA to a team
Examples when would be a good thing to assign a CAPA to an individual
Examples and definitions of teams and team members roles and responsibilities
It can be used and applied in other areas inside and/or outside the organization when and where team work is required and expected
This section by itself can be taken out and applied to other processes and practices within or outside of the organization with the goal of continuous improvement
Module 3
Emphasize the importance and need of completing the verifications and/or validations of the actions taken to ensure that the issue has been resolved and the true root cause of the issue has been removed
Real-life examples and suggestions which can be used immediately after completing the webinar
Module 4
Examples how to appropriately award and recognize teams and individuals for producing the results
Additional references and pointers where more successful examples and instructions can be found so that you and your organization can benefit and profit more from the CAPA process and CAPA teams - and maybe more importantly have those outside the quality department more engaged and interested in participating in CAPA and continuous improvements
Q & A

Who Will Benefit:
Quality Managers
Quality Engineers
Small business owners
CAPA investigators
Inspectors
Six Sigma specialists
Consultants

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

CLIA (Clinical Laboratory Improvement Amendments) Guidelines on Quality Control and Quality Assessment
Start: 06/07/2012 10:00 am
End: 06/07/2012 11:00 am

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
Start: 06/07/2012 2:00 pm

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

Indoor Air Quality in Daycare and Early Learning Facilities
Start: 06/07/2012 2:00 pm
End: 06/07/2012 3:00 pm

Free webinar for daycare owners, operators, workers and parents:

Sign up for this online presentation to learn more about the many facets of Indoor Air Quality, the most common indoor air pollutants in daycare facilities and simple steps to improve the daycare environment for the benefit of the children and the staff.

During the 45-minute webinar, we will cover

• Sources of Poor IAQ
• How Pollutants Affect Children, Caregivers, Parents
• Sound Solutions
• Proven and accepted Air Cleaning Technologies
• Advantages of a Healthy Daycare Environment

The presenter is Julia Gerke, an Indoor Air Quality Research Specialist at Air Quality Academy, whose background in journalism and communications helps her make sense of the latest studies, research and innovations.

We are proud to work with childcare and early learning associations across Canada.

Register now to reserve your seat.

(Other times and dates may be available. For more information, e-mail leif@airqualityacademy.org)

About Air Quality Academy

The Air Quality Academy is a free and comprehensive resource to distribute information, solutions and practical guidance related to indoor air quality concerns.

Air Quality Academy offers complimentary webinars to promote practical solutions to IAQ concerns and support preventative maintenance combined with a rational approach to avoid common air quality problems.

For more information, please visit www.airqualityacademy.org

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