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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 113

Effective Master Planning for Computer Validation

Recorded

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Planning is the most important part of computer validation. Having a good plan in place with owners, deliverables and check points makes validation easy. However, the regulated industry is unsure on how to develop and document such planning.

Key Questions related to plan are are:

  • What do FDA and other regulations say about planning of Computer Validation?
  • What exactly are the expectations of inspectors?
  • What do I really need: A "Validation Master Plan", a "Master Validation Plan" or is a "Validation Project Plan" enough?
  • Who should own all these plans?
  • How to develop such plans?
  • What should be the contents of the plans?
  • Which tools are available to manage and document planning?
  • How to make sure that the plans are properly executed

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 plan examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Planning and documentation requirements in US and EU
  • Terminology and type of planning: validation master plan, master validation plan, validation project plans
  • Developing an effective validation master plan as a frame work for all validation projects
  • Developing a project plan for individual validation projects
  • Contents, deliverables and owners of plans
  • Proper execution of the plan
  • Tools to manage and document planning

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

  • SOP: Validation of Commercial Off-the-shelf Computer Systems
  • Examples:
    - Validation master plan for equipment, computers, spreadsheets and networks
    40+ pages, framework for individual project plans
    - Requirement specifications
  • Warning letters and Inspectional observations related to computer validation.
  • Presentation from FDA's John Dietrick, a compliance officer in the Center's Division of Manufacturing on FDA's concepts for Process Validation. "Without a Validation Master Plan, there may be no direction and little likelihood of success" Mr. Dietrick said. "It is a tool for planning and documentation and is required by EU as spelled out in Annex 15 of the EU (EC) GMP directive". In his presentation Dietrick answered the question: Why do you validate? He presented validation concepts, essential elements of a validation program, validation steps, validation protocols, setting specifications and action limits, change control and contents of a validation report
  • FDA/EU Guidelines and Regulations on validation
  • Other publications.

Who should attend?

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

How to order

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

Replaced by the more recent seminar

Master Planning for Software and Computer Validation

With examples for master plan and several project plans

Click here

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.