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
On-line Audio Seminar 113
Effective Master Planning for Computer
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
Key Questions related to plan are are:
- What do FDA and other regulations say about planning of
- 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
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
- Validation master plan for equipment, computers, spreadsheets
40+ pages, framework for individual project plans
- Requirement specifications
- Warning letters and Inspectional observations related to
- 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
How to order
Pick one of the options in the table that fits your needs.
Replaced by the more recent seminar
for Software and Computer Validation
for master plan and several project plans
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,