Inspection Readiness

The best way to pass an FDA inspection is, of course, to be in compliance. But there are many actions you can take in advance to make the inspection easier for both you and the inspectors. This course takes the participant step-by-step through the entire inspection process and describes various types of inspections. Participants will leave with an understanding of the inspection process, their role in that process, and specific steps for preparing and managing the audit.

COURSE MODULES

Medical Device, Pharmaceutical & Biotech Consulting Firm
  1. Introduction and Preparation
  2. How to Interact with the Regulatory Body
  3. Inspection Structure - Front and Back Room
  4. Mock Inspection Activity

LEARNING OBJECTIVES

Attendees of this course will gain insight into the following:

  • The purpose and types of FDA inspections
  • The Regulatory Requirements and Guidelines relevant to inspections
  • FDA Inspection boundaries for: pictures, sample collection, quality system review
  • The proper way to interact with an FDA investigator
  • FDA Audit terminology
  • Effective personnel management during the inspection: Contact Team, Go-For Team, Tour Leads
  • Developing tour routes
  • Identify and organizing conference rooms for audit interviews

AUDIENCE & DELIVERY

This course is appropriate for individuals who manage Operations, QA, Engineering, Maintenance, or Laboratories; anyone who may be inspected in the near future.

The course is conducted by PathWise facilitators or by certified client instructors. Our facilitators have extensive backgrounds in third party inspection readiness and quality system management.

COURSE DURATION

One Day

FREE DOWNLOAD

Learn how to prepare for an FDA inspection in the free white paper below.

Medical Device, Pharmaceutical & Biotech Consulting Firm

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FDA, CAPA & Regulatory Compliance Training

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