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 156

Computer System Validation

Introduction, Requirements and Strategies for Implementation

Recorded

Software and computer systems used in regulated environments should be validated. But despite its 20-year history and many official guidelines and other publications developed by the FDA, the validation of software and computer systems still confuses people.

Key Questions related to laboratory equipment qualification are:

• What are FDA’s expectations?
• What exactly needs to be validated?
• How to develop an effective validation program?
• How much validation is enough?
• What to validate for Part 11?
• How to document validation plans and results?

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 FDA requirements, present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA/EU guidelines, requirements, inspection and enforcement practices
• Key elements of a computer validation program
  (Planning, DQ, IQ, OQ, PQ)
• Strategies for most efficient testing
• Handling changes: revalidation and documentation
• Reducing costs through risk based validation
• 10 worst mistakes you can make and how to avoid them
• Documentation requirements

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

Master and Project Plans

- Master Plan: Validation of Computer Systems
-Project Plan: Validation of Chromatographic Data Systems

SOPs:

- Configuration Management and Version Control of Software
- Validation of Commercial Off-the-Shelf Computer Systems
- Development and Maintenance of Test Scripts for
Equipment Hardware, Software and Systems
- Risk Based Validation of Software and Computer Systems
- Change Control of Software and Computer Systems
- Validation of Electronic Document Management Systems
- Validation of Spreadsheet Applications
- Retirement of Computer Systems
- Qualification of PC Clients

Gap analysis/checklists:

- Using computers in FDA regulated environments

Templates/examples

- Computer System Identification

Warning letters and Inspectional observations

related to software and computer validation

FDA/EU and International Guidance documents

related to software and computer validation

- FDA Industry Guidance: Principles of Software Validation
- PIC/S Good Practices: Using Computers in GxP Environments
- MWH Japan: Control of Computer Systems in Drug Manufacturing
And more...

Who should attend?

• Managers from purchasing, documentation and operations
• All users of computer systems used in regulated environments
• QA managers and personnel
• GLP/GMP/GCP auditors
• IT managers and personnel
• Consultants
• Teachers

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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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.