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Verification vs Validation-Product, Equipment and QMS Software
Wednesday, August 15th at 8:00am PST
Online sale ends: 08/15/18 at 7:00am PST
Online
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
Fremont, CA 94539
-= series =-
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Description
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

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.

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

Presented By

8:00am to 11:00am
Doors open at 12:00am

General Admission: $290.00

Age
All Ages

Online<br> 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA<br> Fremont, 94539

18004479407

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