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.
Implementing a Bullet Proof Quality System for FDA Audit Success covers topics such as:
- 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
Implementing a Bullet Proof Quality System for FDA Audit Success intended for:
- Quality and Manufacturing Personnel
- R&D Professionals
- QC/QA Personnel
- Regulatory Professionals
- Senior Management
