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 207

Validation of Existing/Legacy Computer Systems

FDA/EU requirements and strategies and tools for implementation

Recorded

When existing or legacy computer systems are used in FDA or equivalent international environments they should be validated, a process sometimes called retrospective validation. While the industry is very well familiar with the validation of new systems, there are many questions about existing or legacy systems.

Key Questions related to legacy are:

• Why should we validate legacy systems - Aren't they are under FDA enforcement discretion?
• We have been using the system since years without problems - why to validate now?
• Do we need user requirements for existing systems?
• What are the exact FDA requirements for existing/legacy systems?
• What is the difference between validation of existing and new systems?
• Haw to validate hardware and software?
• Can we use the system for GxP type work if we have a plan for validation?
• What if the vendor company is not existing any more?
• Can we reuse existing test results as evidence for validation?
• What if the existing system does not have required functionality?
• What to do with network infrastructure?

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:

• Definition of legacy systems and retrospective validation
• FDA requirements and inspection practices
• Industry recommendations, e.g., from the GAMP
• Assessment activities, e.g., gap analysis and risk assessment
• Reviewing and updating the validation master plan for existing systems
• Going through the validation lifecycles from planning to ongoing tests in routine use
• Documenting validation results
• Dealing with requirements for electronic records/signatures: Part 11, New Annex 11

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

• Computer System Validation Master Plan: Updated to include existing systems
• Master Plan- Template - Examples: Retrospective Validation of Computer Systems
• SOP: Retrospective Validation of Computerized Systems
• SOP: Gap Analysis for Computer Systems
• SOP: Change Control of Software and Computer Systems
• Checklist: Retrospective Validation of Computer Systems
• Checklist: Using Computers in FDA Regulated Environments
• Gap Analysis/Checklist: 21 CFR Part 11
• Example: Network Infrastructure and System Identification
• Reference publications: Retrospective Validation of Computerized Systems
• Five FDA Warning letters related to validation of existing systems

Who should attend?

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

How to order

Pick one of the options in the table that fits your needs. 

Recorded seminar - Web download 'Site' offer 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 author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

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 visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.