Process Validation for Medical Devices

Medical device manufacturers can avoid FDA Warning Letters, 483s and enforcement actions with a good understanding process validation principles. But knowing how to proceed is the toughest task as no FDA guidance document is available which talks about it.

This two day interactive seminar is designed to make you understand the regulatory requirements of both FDA QSR and ISO 13485:2003. To compensate for the missing guidance document, the course draws the “how to” answer from various other sources including the GHTF guidance, FDA’s QSIT, FDA Warning Letters, and the guidance document for ISO 13485:2003. This course will help attendees understand the regulatory requirements and the statistical methods needed to perform effective process validation for medical device manufacturing.

For Registration:

http://www.complianceonline.com/ecommerce/control/seminar?product_id=80108SEM&?channel=meditechiq