Implementing a Bullet Proof Quality System for FDA Audit Success

Why Should You Attend:

This webinar will offer an overview of FDA expectations for medical device and combination product manufacturers for auditing their facility’s quality system. It will also cover key audit elements which will help attendees to set up their documentation in order to implement a bullet proof quality system to come out of FDA audits successfully.

Upon completion of this webinar, attendees will get an insight into all aspects of FDA audit requirements for medical devices so that they can prepare well and come out of the FDA audits without observations that can tarnish their product quality and marketing reputation.

Areas Covered in the Webinar:

• Getting to know your Quality System (QS) in its entirety to fulfil FDA requirements for your QS
• Familiarizing yourself with your products from R&D to cGMP production and documentation of the evolution of your commercialized product
• Getting all your paperwork prepared per GDP (Good Documentation Practices) as evidence in order to withstand FDA scrutiny at the FDA audit
• Understanding QSIT ( Quality System Inspection Techniques) requirements for:
• Document Controls, Personnel and Training
• Supplier and Purchasing Controls, Receiving and Shipping Inspections
• Production and Process Controls and Corrective and Preventive Actions
• Packaging and Labelling Controls, Test Equipment, Testing and Laboratory Controls, Out of Spec Testing Requirements