An inspection conducted by the US FDA is a very important milestone in any pharmaceutical company`s lifecycle. A successful inspection opens the door, or retains access to one of the world`s most lucrative markets. When it is unsuccessful the inspection can seriously damage the reputation of individuals within the company and the company itself. Penalties such as Warning Letters and Import Restrictions can easily be applied. Further action such as severe fines and Consent decrees can follow; these measures can seriously affect the viability of the company. FDA look for a culture of Quality that is led from the very top of the company.
The format of this course is a mix of classroom activity and practical workshops to prepare you for different types of FDA inspections and the challenges they present. The course is directed toward personnel from, development, manufacture, quality and/or regulatory compliance who are responsible for FDA inspectable activity relating to the manufacture and quality control of pharmaceutical products for the USA market.
THIS COURSE WILL PROVIDE: - Background to FDA`s Inspection authority
- The background to changing FDA approaches
- The knowledge to help you prepare to successfully host an FDA inspection
- Common FDA inspection target areas/systems
- Running an inspection ready room
- Help in interpreting what a Form 483 actually states and how to formulate your response
