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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 348

New OECD Guide: Using Computer Systems in GLP Studies

Understanding and Implementing the new "Global Standard" for Computer Systems 

Recorded, available with all reference material at any time

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After almost 20 years the OECD has released a new version of the Consensus Document: "The Application of GLP Principles To Computerised Systems". Compared to the older version the new one is more detailed and has some very specific requirements. In addition to validation the new "Global Standard" addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The guide includes all details and what to do but it does not have specific information for implementation. 

Key Questions related to GLP and Computers are

  • Is this guide mandatory or voluntary for GLP environments?
  • Are there any specific or 'new' requirements compared to Part 11 and the old OECD guide?
  • How does it compare with GAMP5 ®
  • How does it compare with the EU-PIC/S GMP Annex 11?
  • Does it require a specific lifecycle model?
  • Can we use the same computer for GLP and non GLP work?
  • Do we need separate computer validation SOPs for GLP and GMP?
  • How to bring existing systems into compliance?
  • Who is responsible for validation: management, study director, QA, IT?
  • Do suppliers and and service providers need to conform to GLP principles?
  • The guide requires to base decisions on  justified risk assessment. How should this be done?
  • What are 'suitable methods' of preventing unauthorized system entry?
  • What does an 'appropriate qualification ' of suppliers mean?
  • Do we have to keep electronic raw data in addition to paper printouts?
  • When can inspectors ask access to study e-records through computers

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:

  • History, and status and future of the OECD guide
  • Scope of the guidance
  • Relation to other documents: Part 11,  Annex 11, GAMP5 ®,
  • The ideal lifecycle model for computer validation in GLP
  • Responsibilities: Management, Study Director, QAU, Users
  • Getting help from system suppliers and service providers
  • Using risk assessment to optimize resources
  • Testing strategies for commercial systems
  • Testing specific configurations: spreadsheets, data bases, data systems
  • Bringing existing systems into compliance
  • Maintaining computers in a validated state: review and revalidation strategies
  • Required validation documents
  • Management of electronic records: acquisition, evaluation, archiving
  • Allocation and implementation of user access rights and privileges
  • The important role of electronic audit trail to demonstrate data integrity
  • Strategies for long term archiving of electronic GLP tudy data
  • Recommendations for implementation: step-by-step

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

Master and Project Plans

- Master Plan: Validation of Computer Systems (M-173)

Primer:

Good Laboratory Practices and Current
Good Manufacturing Practices (M-171)

SOPs:

- Risk Assessment for Systems Used in GxP Environment (S-134)

- Recording of GLP Raw Data (S-149)

- Archiving GLP Data and Other Documents (S-151)

- Risk Based Validation of Computer Systems (S-252)

- Development of Requirement Specifications for Computer Systems (S-253)

-  Periodic Evaluation and Review of Computerized Systems (S-258)

- Configuration Management and Version Control of Software (S-259)

- Change Control of Software and Computer systems (S-262)

- Validation Of Spreadsheet Applications (S-264)

- Retrospective Validation of Computerized Systems (S-269)

- Quality Assessment of Software and Computer System Suppliers (S-274)

- Responsibilities for Computer System Validation (S-277)

- Data Back up and Restore (S-317)

- Handling Contingency Situations for Computer Systems (S-318)

- Disaster Recovery of Computer Systems (S-319)

- Access Rights to Computer Systems and Data (S-320)

- Electronic Audit Trail - Specifications, Implementation and Validation (S-322)

- Review of Electronic Audit Trail (S-323)

- Integrity and Security of Electronic Records (S-324)

- Using Electronic Signatures in Regulated Environments (S-325)

Gap analysis/checklists:

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

Validation examples

- Supplier assessment for a chromatographic data system

-  Supplier assessment for an electronic document management system

Warning letters and Inspectional observations

related to validation and use of computer systems

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

Date, time and duration

Recorded seminar, available at any time with all reference material

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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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.

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 explained FDA's next 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,