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

MessageThis Webinar is over
Date Dec 7, 2018
Time 09:00 AM to 12:00 PM
Cost $ 290.00
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


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