Verification vs Validation-Product, Equipment and QMS Software

Overview:

You will learn What do the U.S. FDA and EU Expect for Verification and Validation, Actions and documentation to meet U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements, ISO 14971 and IEC 62366 considerations, as appropriate.

Why should you Attend:

The FDA / ICH Q-series provide valuable insights for all regulated industries, not just pharma. Why "working definitions"? What's a field proven approach. Requirements to qualifications to test cases to the validation.

Areas Covered in the Session:

Verification or Validation Recent regulatory expectations

The Validation Master Plan and its structure

Product Validation - how it differs from process / equipment V&V

Process / Equipment / Facility Validation including

FDA's recent guidance

Who Will Benefit:

Senior management in Drugs, Devices, Biologics, Dietary

Supplements

QA

RA

R&D

Engineering

Production

Operations

Event Fee: One Dial-in One Attendee Price: US $290.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: support@compliance4All.com

Speaker Profile: 

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.