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Langue du site : Français - English
Réf : 28506
Evènement :Things To Do Immediately About Master Validation Plan 2019

Date :Mardi 29 Janvier 2019

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

Type :Formation - Audience Internationale

Accréditation :--


 

Informations

Overview:
How to develop or improve upon a Master Verification and Validation Plan and System that meets U.S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements.
 
Why should you Attend:
The billions of dollars spent by industry annually for V&V are not providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but proper up-front V&V planning and execution, documented in a corporate MVP and implemented by other V&V documents.
 
Areas Covered in the Session:
The 11 key documents for software validation
Incorporating 21 CFR Part 11 requirements
Suggested "test case" formats
 
Who Will Benefit:
Engineering
Production
Operations
Senior Management in Drugs
 
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.
 
Event Fee: One Dial-in One Attendee Price: US $290.00
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com

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

Things To Do Immediately About Master Validation Plan 2019 Pharmacie - Médecine - Bio-Technologies
education training, training, medical device, technology
Tout public, Engineering Production Operations
50 1 --
English

Divers

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