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 170

Retirement of Computer Systems

Strategies for FDA Compliance and Tools for Implementation

Recorded

Retirement of computer systems used in FDA and equivalent international environments is part of the validation lifecycle and should follow well defined and documented processes. While earlier phases are well understood the industry is unsure on what to do when the systems are taken out of service. Most critical are strategies and procedures to retrieve data after system retirement.

Key Questions related to retirement of computer systems are:

• What are FDA and international requirements?
• What is the impact of FDA's new approach for Part 11?
• What is the business benefit of a controlled system retirement?
• Is there a difference between retirement and decommissioning?
• Who should be responsible for the retirement process?
• How to develop a retirement plan?
• What to do with the records generated by the system?
• How to safely destroy data from the hard disk?
• How to preserve signature/record linking?
• What to do if the native file format is not supported on the successor system?
• Which documents should we develop?
• How much does it all cost?

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 the requirements for retirement of computer system and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA and international regulations and guidelines
• Impact of FDA's narrow approach for Part 11
• Planning for system retirement
• Strategies for data migration and retrieval
• Risk based archiving of e-records
• Criteria for reprocessing
• Responsibilities for system retirement
• Performing system retirement
• Documentation of the retirement process
• Costs of system retirement

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

• SOPs:
  - Retirement of Computer Systems
  - Retention and Archiving of Electronic Records
  - Data back-up and Retrieval
  - Archiving and Retrieval of GMP Data and other Documents
  - Archiving and Retrieval of GLP Data and other Documents
• Templates/Checklist/Examples:
  - Computer System Retirement Checklist
  - Computer System Retirement Plan
• Reference Article
  - Data Migration and Long Term Archiving for Ready Retrieval
• FDA References
  - Requirements for Manufacturing Records
  - Requirements for Laboratory Records
• Warning letters and/or Inspectional observations related to CSV
• FDA Guidance for Industry:
  21 CFR Part 11 Scope and Applications

Who should attend?

• IT Managers and staff
• Operation managers, supervisors and staff
• GLP/GMP auditors
• QA/QC managers and personnel
• Regulatory affairs
• Training departments
• 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.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
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.-

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.