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Verification vs Validation-Product, Equipment and QMS Software

View: 31

Website http://www.compliance4all.com/control/w_product/~product_id=502001LIVE?channel=ourglocal_Aug_2018_SE | Edit Freely

Category QMS Software, Validation-Product, software quality assurance, iso 9001 software, quality system software, best quality management software, Compliance Solutions

Deadline: August 13, 2018 | Date: August 15, 2018

Venue/Country: Online, U.S.A

Updated: 2018-06-07 14:33:24 (GMT+9)

Call For Papers - CFP

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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.