Develop appropriate validation activities to meet U.S. FDA, ICH Q9 and ISO 14971 (Pharmaceuticals Trai)
Venue: Online Event
|Event Date/Time: Apr 28, 2011||End Date/Time: Apr 28, 2011|
A Validation Plan is the backbone of a company's validation activities and provides a clear and concise plan for complying with 21 CFR Part 11. The categorization of software determines the validation activities to be followed.
In this webinar, we will discuss the five categories of software and also focus on the activities required for validation. Examples of each category and activities will be discussed and frequently asked questions will be answered (e.g. Do I have to validate an Excel Spreadsheet?) The components of the Validation Plan will be identified and activities describing timing and roles/responsibilities required for the specific system will be also be discussed.
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