2020 - Implementing a Bullet Proof Quality System for FDA Audit Success

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