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)Learn from the convenience of your desk or with your colleagues in a seminar room
(to learn more about audio seminars, click here)

On-line Audio Seminar 212

Master Planning for Software and Computer Validation

With examples for master plan and several project plans

Recorded (Available with all reference material as mp3 download or on CD)

Planning is the most important part of software and computer validation. Having a good plan in place with owners, deliverables and check points makes validation easy. A master plan increases the efficiency and consistency of validation and answers the inspector's question: what is your approach towards computer system validation. A master plan is also a requirement of European GMPs as defined in Annex 15. It is also the perfect answer to the FDA inspector's question about a company's approach for validation. However, despite of this importance, the regulated industry is unsure on how to develop and document master and project plans for software and computer validation.

Key Questions related to master and project plans 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?
• Should it be developed for a site, a department or at higher levels?
• 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 in time?

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 and International Requirements
• 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
• The benefits of a global validation master plan
• Developing a project plan for individual validation projects
• Responsibilities for planning and deliverables
• Contents and deliverables of a validation master plan and project plan
• Relationship of master plans to other documents: risk plan, training plan, SOPs
• Proper execution of the plans
• Templates and examples

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

• Computer System Validation Master Plan with 20 templates/examples
• Validation Project Plan Template and Examples
  (can be used as example for other projects)
  -  Electronic Document Management System
  -  Chromatographic data system system
  -  Excel Spreadsheet Application
• SOPs:
  - Validation of Commercial Off-the-shelf (COTS) Computer Systems
  - Validation of Document Management Systems
  - Auditing Computer Systems
  - Risk Based Validation of Computer Systems
• Checklist:
  - Validation Master Planning
  - Using Commercial Off-the-Shelf Computer Systems
• EU GMP Annex 15: Validation and Qualification (Requires Validation Master Plan)
• FDA 483 inspectional observations and warning letters with deviations related to software and computers
• FDA regulations and guidelines related to computer validation
• And more....

Who should attend?

• Validation specialists
• QA 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.-
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.