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Event :Best Practices to Help you Pass an FDA Computer System (Validation)

Date :Friday December 07th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


Further information

This webinar will help you understand the FDA's current thinking on 
computer systems that are validated and subject to inspection and audit.
Areas Covered in the Session:
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Archival to ensure security, integrity and compliance
Validation Strategy that will take into account the system risk assessment 
and system categorization (GAMP V) processes
Recent FDA findings for companies in regulated industries
Who Will Benefit:
Anyone who is involved in the development, testing, manufacturing, 
storage, handling and distribution of product must understand and 
conform to FDA requirements for data quality and integrity, and computer 
system validation (CSV)
Finally, anyone who is acting as a consultant or contractor to a company 
in an FDA-regulated industry should attend to ensure they are able to 
bring the most current knowledge and expertise to their assignment
Speaker Profile:
Carolyn (McKillop) Troiano has more than 35 years of experience in the 
tobacco, pharmaceutical, medical device and other FDA-regulated 
industries. She has worked directly, or on a consulting basis, for many of 
the larger pharmaceutical and tobacco companies in the US and Europe, 
developing and executing compliance strategies and programs.
Event Fee: One Dial-in One Attendee Price: US$290.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Further information

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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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Best Practices to Help you Pass an FDA Computer System (Validation) Medicine - Bio-Technologies - Toxicology - Public Health - Pharmacy
education training, medical conference
Everyone, Lab Managers Process Engineers Technical Managers in General
501 1 --


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