Attend Our Training Workshop: Preparing for an FDA Inspection

The Regional Pharmaceutical Manufacturing Expo is a one day event that will be a marketplace for manufacturing decision makers to discuss evolving solutions and technological advances in pharmaceutical and biologics manufacturing.

In addition, attendees have the option to attend training workshops and presentations throughout the day with leaders from today’s most innovative and mature service companies. Registration for the training workshops are free for all RPM Expo attendees.

Led by Michael Falkow of the Lancer Group, Preparing for an FDA Inspection will take place from 2:30 PM to 4:30 PM and will include lunch. This workshop is being held courtesy of the Mercer Institute of Management & Training and the Project Management Institute, New Jersey Chapter. Below is a summary of the workshop:

Attendees will learn 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.

To complete your complimentary registration for this training workshop, please click here. Registration for training workshops includes lunch and full access to the Expo and plenary sessions.