Validation Planning and Documentation in 2016 by Compliance4all
- September 26, 2016
- 660 Views
- 0 Likes
- 0 Comment
The verification and validation of medical software is coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP, 21 CFR Part 11, "Electronic Records" / "Electronic Signatures", and other applicable industry software validation models, coupled with the ISO 14971 / ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
Why should you attend:
Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. A quick review of Internet forums will show much confusion about the subject. Software is being developed for medical imaging, and even thought control of computers. It is increasingly being used for e-records and e-signatures.
Areas Covered in the Session:
Verification or Validation - FDA Expectations
The Project Validation Plan
An FDA-accepted Documentation "Model"
Product and Process / Test / Facilities / Equipment Software V&V
When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
GAMP / Other Considerations
The FDA's 11 Key V&V Documentation Elements
"White Box" and "Black Box" Validations
Who Will Benefit:
Senior management in Drugs, Devices, Combination Products, Biologics, Dietary Supplements
QA / RA
Software development, programming, documentation, testing teams
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/2aVOwae
Twitter Follow us – https://twitter.com/compliance4all
Facebook Like us – https://www.facebook.com/Compliance4all