Implementing a Bullet Proof Quality System for FDA Audit Success

Implementing a Bullet Proof Quality System for FDA Audit Success is an event dedicated to the FDA expectations in medical device industries for setting up a quality system for FDA audit readiness.

Topics

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

Who should Attend

• Quality and Manufacturing Personnel
• R&D Professionals
• QC/QA Personnel
• Regulatory Professionals
• Senior Management