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Reviewing Computer Validation Documents

John Murry, FDA Computer Validation Expert

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

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 221

Latest Compliance Updates for Computer Systems

Get Recent Conference News on FDA and EU Requirements at your Desk

Recorded, Available with all reference material

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Staying compliant for computers and electronic records is a challenge. While FDA and EU regulations don't change frequently, guidelines and even more importantly enforcement practices do. And industry organization such as GAMP frequently release good practice guides for cost effective implementation. In addition industry experts and FDA officials share their experience on current inspection practices and recommendations at conferences. The question is how to get all this important information without traveling to all conferences

Key Questions are:

  • What are FDA's current inspection practices for computer validation?
  • What are key findings during inspections?
  • What are key FDA findings when reviewing documentation for New Drug Applications?
  • What are FDA's plans for Part 11?
  • What is the status and recommendations for the new EU Annex 11
  • What are latest industry practices for cost effective validation
  • What is the experience with GAMP 5
  • There is lots of talking about risk based validation, but are there practical examples, and is it enforced by FDA and EU inspectors?

How does the this audio seminar help:

All these questions have been extensively discussed and answers have been provided at IVT's recent 10th anniversary of the Annual Computer System Validation Conference in Arlington. Summary recommendations will be presented by. Dr. Ludwig Huber in a new interactive audio seminar. Dr. Huber has been a plenary speaker at all 10 conferences and knows theory and practice of computer validation in and out. During the seminar, Dr. Huber will give practical recommendations based on the conference outcomes.  After the seminar, an extensive list of reference material like SOPs, worksheets, templates examples and slide presentations will help immediate and cost effective implementation.

During the interactive presentation you learn key points about:

  • FDA findings when reviewing computer validation documents, as presented by FDA's software and computer system expert John Murray
  • New requirements of the new EU Annex 11 and comparison with Part 11, presented by Dr. Ludwig Huber
  • FDA and EU recent inspection and enforcement practices, shared experiences
  • Status Update on 21 CFR Part 11, answered by FDA's John Murray
  • Bringing existing systems into compliance - Recommendations from a workshop session.
  • Validation controls to assure data integrity - Strategies and examples presented by Monica Cahilly in a workshop
  • Implementing new guidelines for laboratory computers - GAMP 5, Annex 11 and USP <1058>, interactive discussion session
  • FDA expectations for CSV and data integrity - Presented by former FDA computer expert - Martin Browning
  •  Electronic Audit Trail: - Case studies discussed by Dr. Ludwig Huber

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

  • EU ANNEX 11 (Version 2008)
  • Checklist: EU Annex 11 (Version 2008)
  • John Murray's PowerPoint Presentation: Reviewing Computer Validation Documents
  • SOP: Validation of Laboratory Computer Systems
  • SOP: Risk Based Validation of Computer Systems
  • SOP: Archiving and Retrieval of GMP data and other Documents
  • SOP: Retrospective Validation of Computerized Systems
  • Validation Example: Requirement Specifications for Electronic Audit Trail:
  • Video presentation: Understand and Implement the New Annex 11 - Presented at the 10th Annual IVT Conference by Dr. Ludwig Huber
  • SOP: Electronic Audit Trail - Specification, implementation and validation
  • Case Studies - When do we need electronic audit trail?
  • FDA Presentation: FDA Regulatory Perspective: Data Integrity
  • 10 recent FDA Warning Letters/483's with deviations related to CSV and data integrity

Who should attend?

  • IT managers and professionals
  • QA managers and personnel
  • All users of computer systems working in FDA/EU regulated environment
  • Validation project managers
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

Date, time and duration

Order at any time, replay at any time.

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.