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10+ Best Practices Reference Documents: All included in the seminar

Includes Links to FDA Regulations related to Electronic Records and Signatures

Reference material includes examples from most recent 483's and warning letters related to electronic audit trails

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 182

Electronic Audit Trails for FDA Compliance

- Requirements - Implementation - Validation - Documentation -

Recorded

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Audit trails are required by various regulations. For example, FDA's and international GLP, cGMP and GCP regulations require to document changes to data with the date and the individual who made the change. FDA's 21 CFR Part 11 and EU Annex 11 require computers to record the changes to automated systems. After some period of enforcement discretion the FDA is enforcing electronic audit trail. And deviation reports are getting more and more specific. Most recent examples are: "The firm's review of laboratory data does not include the audit trail/revision history to determine if unapproved changes have been made." and "The audit trail generated within xxx does not truly reflect the identity of the responsible individuals".  More than ever, the industry is unsure what to do.

Key Questions related to Audit Trails

  • What are FDA requirements for GLP/GMP/GCP?
  • What are international requirements (EU, Asia, Australia)?
  • Why should I care about audit trails, they are under enforcement discretion?
  • My software does not provide electronic audit trail, can I use manual audit trail?
  • What exactly should be documented in the audit trail?
  • What does it mean: Base your decision on justified and documented risk assessment?
  • Can e-audit trial substitute signatures?
  • Excel has a tracking function. Is this equivalent to audit trail?
  • Should electronic audit trails be reviewed?
  • What will be the audit trail requirements for FDA's 'New' Part11
  • For how long should electronic audit trails be archived?

How does the 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, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • FDA GLP/GMP/GCP requirements for audit trail
  • Part 11 requirements for electronic audit trail: now and in the future
  • International requirements
  • The importance of audit trails to ensure and document data integrity
  • The role of audit trails for electronic signatures
  • Documentation requirements for changes on paper
  • Documentation requirements for electronic audit trail
  • Clear identification of the individual who made the change
  • The important role of user-specific automated time-outs
  • Examples when electronic audit trails are a must
  • Examples when electronic audit trails are not required
  • Requirement specifications for audit trails
  • Circumstances when e-audit trail can substitute signatures.
  • Implementing electronic audit trails
  • Validation of audit trail functionality
  • Going through case studies from laboratories, offices and manufacturing

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

  • SOP: Electronic Audit Trails - Specifications. Implementation and Validation
  • SOP: Retention and Archiving of Electronic Records
  • SOP: Access Control to Computer Systems and Data
  • Six Case Studies for Electronic Audit Trail
  • Validation example: Requirement Specifications for Electronic Audit Trail
  • Validation example: Test cases for electronic audit trail
  • Checklist for Electronic Audit trail
  • Reference paper: Ensuring Data Integrity of Electronic Records
  • SOP: 21 CFR Part 11 - Scope and Controls
  • SOP: Risk Assessment for GxP Systems
  • Five Warning letters and/or Inspectional observations related to electronic audit trail
  • FDA guidance documents and predicate rules

Who should attend?

  • Documentation department manager and staff
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • 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.