Labcompliance On-line Audio Seminar

On-line Audio Seminar 113

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)

Effective Master Planning for Computer Validation

Recorded

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

About Dr. Ludwig Huber

Dr. Ludwig Huber is worldwide director for FDA compliance at Agilent Technologies and author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years.

He 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.

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.

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 over the phone
5. Ask questions through web forms

Attendees can discuss and ask questions over the phone, fax or e-mail.

The transcript and questions and answers have been be posted at the seminar website. This includes questions that came through e-mail and life during the seminar.

How to order

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

Recorded seminar - Standard (Instant download)
Single person, includes all reference material From the convenience of your desk	US$ 249.-
Recorded seminar - Site offer (instant download)
Multiple persons - single site Meet in a seminar or conference room or share the audio file and reference material at your site	US$ 349.-
CD - Recorded audio seminar
Get the CD in your mail Useful if you can/could not attend the on-line seminar. Order includes all reference material.	US$ 349.-
Recorded Seminar plus reference material - Special offer for Labcompliance User Club Members)
(for user club information and registration, click here)	US$ 149.-

Best Practices

all included in the seminar handout - and more!!!