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Langue du site : Français - English
Réf : 27502
Evènement :Verification vs Validation-Product, Equipment and QMS Software

Date :Mercredi 15 Août 2018

Lieu :En ligne (Internet, Visioconférence, ...)

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

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
http://www.compliance4all.com/control/w_product/~product_id=502001LIVE?channel=doctorama_Aug_2018_SEO

Renseignements

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Annonceur

Compliance4All
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 [...]

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Précisions

Verification vs Validation-Product, Equipment and QMS Software Médecine - Toxicologie - Santé Publique
healthcare, education training
Tout public, R&D Engineering Production Operations Consultants, Others Tasked with Product
50 1 --
English

Divers

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