Overview: In this webinar speaker will discuss the best practices necessary to develop an integrated laboratory and business data collection, analysis and reporting computer system validation program.
Why should you attend: Those users accessing the business system must also not be able to enter or alter data directly into the laboratory system, unless it is clearly a requirement based on the process being followed.
Areas Covered in the Session: Identify the key input and output points that will warrant greater scrutiny as the integrated system is tested and validated Discuss the steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs Learn how to leverage these practices across all systems by creating a standardized program for integrating FDA-regulated and non-regulated systems Understand the additional training that must be provided to business and IT staff involved in the integration process
Who Will Benefit: Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts
Speaker Profile: Carolyn 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 Email: support@compliance4All.com
One Dial-in One Attendee
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.