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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 127

21 CFR Part 11 - Electronic Records and Electronic Signatures

Introduction and Strategies for Cost-effective Compliance


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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. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP).

Questions are:

  • What are the key requirements?
  • What are the issues?
  • 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 archive records: paper vs. electronic records?
  • 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 business practices
  • 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:

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, gap analysis, implementation plan templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn:

  • Overview on Part 11 Requirements
  • FDA's new interpretation: learning from the guidance and recent FDA conference presentations
  • FDA's current inspection and enforcement practices: a risk based approach
  • Recommendations from industry task forces, e.g., GAMP
  • Strategy for cost-effective implementation of the new guidance
  • Special attention to audit trail and long term archiving&retrieval
  • Justification and documentation for the FDA and your management
  • Examples from laboratories, offices and manufacturing
  • FDA's next steps
  • Most likely changes in the new part 11

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

  • SOPs:
    - Risk Assessment for Systems Used in GxP Environments
    - Define and document scope and controls for part 11
    - Training for GxP and Part 11
    - Development and Use of Spreadsheets in Part 11 and GxP Environments
    - Validation of Commercial Off the Shelf Systems
    - Validation of Spreadsheet Applications
    - Retention and Archiving of Electronic Records
    - Risk based validation of software and computer systems
  • Gap analysis/checklists:
    - 21 CFR Part 11
    - Using Computers in FDA Regulated Environments
  • Templates/examples
    - Part 11 remediation project schedule
    - URS for Part 11
    - Most frequently asked questions and answers
  • Warning letters and Inspectional observations related to 21 CFR Part 11
  • FDA/EU Guidance documents related to electronic records/signatures and computer validation

Who should attend?

  • 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

Understanding FDA's 21 CFR Part 11

Introduction and Strategies and Tools for Implementation

Click here

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.