Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

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Verification vs Validation-Product, Equipment and QMS Software

Start Date : August 15, 2018
End Date : August 15, 2018
Time : 8:00 am to11:00 am

Phone : 800-447-9407
Email : support@compliance4All.com

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

Website

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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