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SPECIALITES MEDICALES ...

Verification vs Validation-Product, Equipment and QMS Software

Du Mercredi 15 Août 2018 au Mercredi 15 Août 2018 à CA
A partir de: 08:00
Secteurs concernés: Biochimie -Biotechnologie -
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
PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Professionnel
Audience: Internationnale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: BIOCHIMIE
Secteurs concernés: Biochimie -Biotechnologie -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-8171
Verification vs Validation-Product, Equipment and QMS Software
Publié sur congres-medical.com le : 2018-06-28 11:14:40
Congrès, formations ou conférences médicales en BIOCHIMIE
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