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
To share this seminar info with your colleagues, click here.

On-line Audio Seminar 271

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded, available with all reference material at any time

Periodic Evaluation and Review of critical computer systems assures that the system is operating within its validated state. The FDA expects a periodic evaluation and periodic evaluation of computer systems became a legal requirement for the European market after July 1, 2011. Chapter 11 of the new EU GMP Annex 11. However, companies are unsure how to conduct and document periodic reviews.

Key Questions related to Evaluation and Periodic Reviews of Computer Systems are:

There are FDA waning letters about missing periodic review, what is the legal basis for this?
What are exact FDA and international requirements?
What are the benefits of periodic evaluation and review?
Why should we do reviews, we have validated our system and follow procedures for changes?
Does periodic review substitute regular revalidation?
What is the recommended frequency reviews: 3, 6, 12, 24 months, or more?
What events trigger periodic review, change control, system failures, others?
Where to get inputs for periodic inputs?
Who is responsible for regular evaluation and periodic review?
What is the difference between gap analysis and periodic review?
What should we look at for evaluation and reviews?

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 regulations and guidelines
Inspection and enforcement practices
Purpose and objectives of the evaluation and review
The role of periodic evaluation and review vs. internal audits and gap analysis
Developing an SOP for evaluation and review
Responsibilities, tasks and owners
Frequency and timing of evaluations and reviews
Criteria and justification for frequency or review vs. revalidation
Inputs for reviews
The review process from planning to documentation
Corrective and preventive action plans
Documentation for the FDA and other agencies

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

PowerPoint Presentation
Script
SOPs
- Periodic Review and Evaluation of Computerized Systems
- Change Control of Software and Computer Systems
- Configuration Management and Version Control of Software.
Checklist: Periodic Evaluation and Review of Computerized Systems
Forms and blanks
- Documenting Deviations of Computer System Reviews
- Documenting Corrective Actions of Computer System Reviews
Warning letters and/or Inspectional observations related to computer system validation
Others

Who should attend?

Industry

Pharmaceutical development and manufacturing
Biopharmaceutical development and manufacturing
Medical device
Blood testing/Clinical testing

Functions

IT managers and system administrators
QA managers and personnel
QC and Lab managers
Validation specialists
Regulatory affairs
Human resources (HR) managers and staff
Training departments
Documentation department
Consultants

Date and time

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.-

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:

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 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.

Dr. 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 explined FDA'snext 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,