Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement

Overview:

This webinar will focus on the key areas that are most important for protecting the validity of data that is regulated by FDA, and is typically housed electronically in computer systems.

Why should you Attend:

This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

Areas Covered in the Session:

FDA Regulatory Trends

FDA Response to Change

Recent FDA findings for companies in regulated industries

Recent trends in technology that need to be addressed in the CSV approach

Industry Best Practices

Who Will Benefit:

Clinical Data Scientists

Analytical Chemists

Compliance Managers

Laboratory Managers

Automation Analysts

Manufacturing Managers

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: compliance4all14@gmail.com

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.