GDP to Support FDA Computer System Validation

  • 150.00 Dollar US$
  • Published date: May 23, 2019
    • Fremont, California, United States

This webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails.

Why should you Attend:
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection.

Areas Covered in the Session:
21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Data Archival to ensure security, integrity and compliance
Learn the requirements for documenting efforts related to systems governed by FDA

Who Will Benefit:
You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system
This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance

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 $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

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