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Labcompliance On-line Audio Seminar

On-line Audio Seminar 152

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)

How to Prepare Your Organization for the 'New' Part 11

Learn What's Coming and How to Implement


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In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. This was done in response to requests from the industry. With this regulation, entitled Rule 21 CFR Part 11, electronic records can be equivalent to paper records and handwritten signatures. However, this first release was almost impossible to implement. Therefore the FDA plans to release a new version in 2007. However, the industry is unsure what to do and what the changes will be.

Questions are:

  • What are the key requirements of Part 11?
  • Which ones will stay, which ones will go away?
  • What is is good time to plan for and implement Part11
  • We already have a Part 11 program: what should we change
  • How can we be sure that we do it right this time?
  • 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 on-line audio seminar help:

Based on presentations, publications and private communications with FDA professionals it is quite easy to predict what the changes will be. Answers to the question will be presented by the Part 11 world expert 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, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn:

  • Overview on the spirit of Part 11 and requirements
  • FDA's current inspection and enforcement practices: a risk based approach
  • Recommendations from industry task forces, e.g., GAMP
  • 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
  • Case studies from laboratories, offices and manufacturing

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

Part 11 Compliance Master Plan

- Ideal to develop or update your company's Part 11 programSOPs:
- 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/checklists:
- 21 CFR Part 11Templates/examples
- 10 Part 11 Case Studies
- Requirement Specifications for Part 11
- Most frequently asked questions and answers

Recent FDA Presentation about Part11

George Smith, FDA: Part 11 - Where we were, Where we are, Where we're going.

Warning letters and Inspectional observations related to 21 CFR Part11FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend?

  • Part 11 groups
  • 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

Replaced by the more recent seminar

Implementing FDA's 'New' 21 CFR Part 11

Strategies and 10 Case Studies from Manufacturing, Offices and Laboratories

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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 over the phone
  5. Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

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.