Process Validation for Medical Devices - The Regulatory Approach January 31, 2013

This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.

Why Should You Attend:

Process validation is one of the most common citations in medical device Warning Letters. This webinar explains the fundamental requirements for process validation with a focus on FDA QSR, but includes ISO 13485:2003. You will learn the regulatory requirements for process validation, the traditional components of process validation (IQ, OQ, and PQ), and the content of protocols and reports. The webinar examines FDA Warning Letters to help understand the requirements and explain what FDA Investigators look for. Because FDA Investigators follow the Quality System Inspection Technique (QSIT), the webinar explains the objectives and links them to the regulation and the Warning Letters.

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702673?channel=yahooevent