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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 174

Implementing FDA's 'New' 21 CFR Part 11

Strategies and 10 Case Studies from Manufacturing, Offices and Laboratories

Recorded

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The FDA has changed the approach and is preparing a new major revision for Part 11. The content of the new regulation is very well defined and now is a good time to learn what's coming and prepare your organization for the upcoming changes. The best way to learn about Part 11 requirements and implementation is through case studies. In this interactive seminar we will go through 10 case studies from Pharmaceutical, Biopharmaceutical and Device Industry. All are very well documented and the recommendations are justified. The case studies answer all questions that frequently come up for Part 11 implementation.

Key Questions are:

  • What are the key requirements of Part 11?
  • Which ones will stay, which ones will go away?
  • We already have a Part 11 program: what should we change?
  • How can we be sure that we do enough but not too much?
  • What is FDA's new scope and current thinking?
  • Which systems should comply with Part 11
  • When is electronic audit trail a 'must'?
  • How to deal with legacy systems?
  • How to develop and implement a gap analysis and remediation plan?
  • What is FDA's current thinking and enforcement strategy?
  • How to document risk assessment for Part 11
  • Where to get reference material (gap analysis, examples, worksheets, SOPs) for easy implementation?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like SOPs and well documented case studies with justifications will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA's current inspection and enforcement practices: a risk based approach
  • FDA's new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions
  • Existing requirements that will go away
  • New requirements of the 'new' Part 11
  • Recommended changes to existing Part 11 programs to reduce costs
  • Strategy for cost-effective implementation of the 'new' Part 11:A six step plan
  • Justification and documentation for the FDA and your management
  • 10 Case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management.

And for easy and instant implementation:
download 10+ documents from special seminar website

  • Part 11 Compliance Master Plan
    - Ideal to develop or update your company's Part 11 program
  • 10 Case Studies
    - All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and and justifications for the FDA and your management
  • SOPs:
    - Define and Document Scope and Controls for Part 11
    - Risk Assessment for Systems Used in GxP Environments
    - Training for GxP and Part 11
    - Retention and Archiving of Electronic Records
  • Gap analysis/checklist: 21 CFR Part 11
  • Templates/examples
    - Requirement Specifications for Part 11
    - Most frequently asked questions and answers
  • Warning letters and Inspectional observations related to 21 CFR Part11
  • Recent FDA Presentation with Part11 Update
    George Smith, US FDA, Member of FDA's Part11 Task Force, Presented in April 2007
  • FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend?

  • Part 11 groups in Bio(pharmaceutical) and device industry
  • System owners
  • Software developers
  • IT managers and system administrators
  • QA managers and personnel
  • Analysts and lab managers
  • Validation professionals
  • Training departments
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.