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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.

On-line Audio Seminar 167

Computer System Validation for GLP

How much is enough?

Recorded

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By far the majority of presentations and seminars on computer validation discuss and present requirements for pharmaceutical&API manufacturing which has to comply with stringent requirements of GMP regulations. There is hardly anything about requirements for development laboratories and GLP studies. On the other hand there are guidelines with specific requirement for validation and using computers in GLP environments, so there are many open questions on what to do.

Key Questions related to GLP and Computers are

  • Where can I find official guidelines on validation of computer systems in GLP environments
  • Do we have to follow stringent GMP requirements or is there some room for lighter validation
  • Do GLP regulations have specific requirements for software and computer validation
  • What exactly needs to be validated?
  • Who is responsible for validation: management, study director, QA?
  • How to develop an effective validation program?
  • How much testing is enough?
  • Can we take advantage of the risk based approach?
  • Does GLP need to comply with Part11?
  • Can we use the same computer for GLP and non GLP work?
  • Do we need separate SOPs for GLP and GMP?
  • How to validate networks and Excel?
  • How to validate existing (legacy) systems?

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

During the interactive presentation you learn about:

  • FDA/EU requirements for using computer in GLP environments
  • The "FDA Hierarchy of Computer Concerns"
  • Contents and meaning of the OECD consensus document on using computers for GLP studies
  • Responsibilities of QAU, study director, IT, users
  • Key elements of a GLP computer validation program
    (Planning, DQ, IQ, OQ, PQ)
  • Strategies for most efficient testing
  • Handling changes: revalidation and documentation
  • Reducing costs through risk based validation
  • Using computers for GLP and non GLP Work
  • Part 11 compliance for GLP studies e.g., do we need e-audit trail?
  • How to archive GLP data for more than 10, 15 ?? years
  • 10 most expensive mistakes you can make and how to avoid them
  • Documentation requirements
  • How to archive records: paper, electronic?

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

Master and Project Plans

- Master Plan: Validation of Computer Systems

Primer:

Good Laboratory Practices and Current Good Manufacturing Practices

SOPs:

- Configuration Management and Version Control of Software
- 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
- Recording of GLP Raw Data
- Archiving of GLP Data and other Documents
- Retirement of Computer Systems

Gap analysis/checklists:

- Using computers in FDA regulated environments
- Good Laboratory Practice Regulations

Templates/examples

- Computer System Identification

Warning letters and Inspectional observations

related to software and computer validation

FDA/EU and International Guidance documents

- OECD Consensus Document:
The Application of the Principles of GLP to Computerised Systems
- FDA Industry Guidance: Principles of Software Validation
- Guidelines for the archiving of Electronic Raw Data in a GLP Environment
- Guidelines for the validation of computerised Systems in GLP
- Guidelines for the management of electronic SOPs in GLP
- Guidelines for the acquisition and processing of electronic raw data in a GLP environment
- PIC/S Good Practices: Using Computers in GxP Environments
- MWH Japan: Control of Computer Systems in Drug Manufacturing
And more...

Who should attend?

  • GLP study directors
  • Validation specialists
  • QAU managers and personnel
  • Regulatory affairs
  • IT department
  • Training department
  • Documentation department
  • 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.-
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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.