Training Workshop A:
12:00-2:00pm EST

Preparing for an FDA Inspection

Courtesy of The Mercer Institute of Management & Training

Michael Falkow Independent Consultant The Lancer Group

Michael Falkow
Independent Consultant
The Lancer Group

Led by Michael Falkow of the Lancer Group, Preparing for an FDA Inspection will give attendees an overview of the roles of a company in preparing for an FDA inspection and actions during an FDA inspection (both your company and the FDA).  Attendees will also learn the Establishment Inspection Report (EIR) response procedure, some common inspection findings and common inspection follow-up actions.  How to respond to a list of inspectional observations (FD Form-483) will also be presented.

Outline:

  • Why FDA inspections are performed and the different types of inspections
  • The different types of FDA inspections
  • Overview of the inspection process
  • How to efficiently prepare for and perform during an inspection
  • Inspection report response procedures
  • Common inspection observations

The RPM Expo will serve as an opportunity for decision makers to gain access to the resources required to implement effective solutions in today’s highly regulated environment and provides  a marketplace for manufacturing decision makers to discuss evolving solutions and technological advances in pharmaceutical and biologics manufacturing.

Registration for training workshops includes full access to the Expo and plenary sessions.