Preparing for and handling FDA Laboratory GMP inspections (Laboratory)
Venue: Online Event
|Event Date/Time: Oct 15, 2010||End Date/Time: Oct 15, 2010|
The FDA inspection is one of the primary means by which the organization is able to present itself to the FDA. Both the stringency and frequency of Regulatory Inspections by the FDA is expected to increase in the coming months and years.
Therefore preparation for inspection forms one of the key activities for the laboratory as well as the QA and RA personnel who are associated with the laboratory. Preparation for an inspection needs to begin well before the inspection is expected to ensure that it proceeds smoothly. Poor preparation or lack of knowledge of expectations may result in avoidable 483s and warning letters.
This webinar will begin with an overview of the FDA GMP Inspection process. The expectations for each of the Lab cGMP systems will be reviewed. Key target areas during regulatory inspections will be discussed. The Workshop will conclude with a discussion about how to prepare for inspections and procedures to follow during and after an inspection.
Areas Covered in the Seminar:
Purpose of an FDA inspection.
Inspection red flags.
Inspection Target Areas.
Preparing for an inspection.
Steps to follow during inspections.
How to respond to 483s.