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Best Practices to Help you Pass an FDA Computer System (Validation)
Friday, December 7th at 9:00am PST
Online sale ends: 12/07/18 at 8:00am PST
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539
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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
Email: support@compliance4All.com
Additional Information
One Dial-in One Attendee Price: $290.00

Presented By

9:00am to 12:00pm
Doors open at 12:00am

General Admission: $290.00

All Ages

Online<br> 161 Mission Falls Lane, Suite 216,<br> Fremont, 94539




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