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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
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On-line Audio Seminar 258

Revalidation of Computer Systems for FDA& EU Compliance

With strategies and tool kits for cost-effective implementation

Recorded, available at any time

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Computer systems are not static, they undergo many changes during their life. FDA and international agencies require that software and computer systems should be revalidated after changes that may have a negative  impact on the validation status. And even though there is no obvious change, computer systems  may have to be periodically revalidation. While requirements for initial validation are well known and most companies have reliable and proven procedures this is not the case for revalidation. Companies are unsure what, when and how much to revalidate, but there are many other questions.

Key Questions related to revalidation are:

  • Where can I find FDA requirements for revalidation?
  • Should we revalidate OQ or for PQ?
  • Software does not change over time, so why should we revalidate software?
  • We formally review our computer systems every year. Do we have to revalidate even though there are no changes?
  • How frequently should we revalidate?
  • Which changes require revalidation?
  • Can we avoid revalidation if we have an ongoing performance monitoring program?
  • Should we validate software when we upgrade the operating system?
  • What to do after we install a Microsoft security patch?
  • Should we conduct the same tests as for initial validation or can we take shortcuts?
  • The initial validation was done by the vendor, can we do the revalidation by ourselves?
  • What should we do if the system does not pass our initial acceptance criteria?
  • Should we perform preventive maintenance before revalidation of equipment?
  • Which type of documentation should be updated? DQ, IQ, OQ, PQ?

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 primers, SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Regulatory requirements and enforcement practices
  • Developing a strategy for revalidation
  • The difference between time based and event based revalidation
  • Criteria for time based revalidation
  • Incidents requiring revalidation
  • Revalidation after application software upgrades
  • Validation tasks after installing security and other patches
  • Handling 'like-for-like'  changes
  • Risk based approaches to define extent of testing
  • Risk based approaches to frequency of revalidation
  • Documentation update after revalidation

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

  • SOP: Revalidation of Software and Computer Systems
  • SOP: Requalification of Equipment
  • SOP: Handling Security Patches
  • SOP: Change Control of Software and Computer Systems
  • Computer System Validation Master Plan (with chapters on revalidation)
  • Checklist: Revalidation of Computer Systems
  • Example: Network Infrastructure and System Identification
  • Five FDA Warning letters related to revalidation of computer systems

Who should attend?

  • ITV managers and Personnel
  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Human resources (HR) managers and staff
  • Documentation department
  • Consultants
  • Training departments

Date, time and duration

Order at any time, replay at any time, download the reference material 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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Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11


Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,

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.