Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.
Why should you Attend:
The attendee will also learn how to develop a standard approach to planning, executing and documenting efforts that involve recovery of day-to-day business operations and data in a manner that complies with FDA guidelines. Some people may be new to the concept of validation and FDA regulation, and will have to be coached on how to follow any necessary procedures required for compliance.
Areas Covered in the Session:
Gain an understanding of disaster recovery and business continuity planning
Develop the ability to apply FDA compliance requirements when developing a disaster recovery and business continuity plan
Understand the best practices for developing a disaster recovery and business continuity plan
Who Will Benefit:
Information Technology Analysts
QC/QA Managers and Analysts
Clinical Data Managers and Scientists
Lab Analysts and Managers
Computer System Validation Specialists
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
Compliance4All DBA NetZealous,