This seminar is broken into two phases.  Phase one will build basic knowledge of the inspection – the who, what, and when.   Phase Two will delve into the how of the inspection from the perspectives of the FDA and those being inspected.

One of the key components discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Another key component of this seminar is the discussion of the tricks and techniques that inspectors use to elicit information.  How you react and respond when they occur could impact your results.

Other key communication skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

We will complete the seminar by discussing how to handle, in the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

Areas Covered:-

Part - 1 Setting the Stage

• FDA Inspection Operations – how they do it
  • Risk-Based approaches for prioritizing sites for GMP Inspection
  • ICH Q9/Q10
• Types of Inspections
  • Pre-Approval
  • Post-Approval
  • Product Surveillance
  • For Cause
• What gets Inspected?
  • Good Clinical Practice (GCP),
  • Good Laboratory Practice (GLP), and
  • Current Good Manufacturing Practice (cGMP).
• Who gets inspected?
• The Systems-Based approach
• Inspectional Trends
• Enforcement

Part - 2 Preparation, Inspection Conduct, and Do’s and Don’ts

• The FDA Investigator
  • How inspectors are guided through their investigations.
• Preparation
  • General
    • The steps to be performed in inspection preparation.
    • Gap analysis and root cause determination
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Current Good Manufacturing Practice (cGMP)
    •  The role of GMPs in FDA inspections.
  • The Quality System Inspection Readiness process.
  • Preparing your records and documents, particularly your CAPA process for an FDA inspection.
  • The importance of data integrity to compliant operations and what inspectors look for in this area.

Background:-

The FDA has been increasing its surveillance of regulated industries. While it is a given that companies must meet their regulatory requirements, how company staff handle an audit and interact with FDA inspectors, can mean the difference between a successful or an unsuccessful FDA audit. The cost of an ineffective interaction can be staggering.

Why Should You Attend:-

If you are in any regulated business - pharmaceuticals, or medical devices, you will experience an inspection by the U.S. Food and Drug Administration (FDA). According to the Food, Drug, and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Depending upon the inspection type and the circumstance, inspections may occur more frequently.  The outcome of those inspections can have a grave significant impact on your business even if you and your colleagues have done everything “right.”  How you and others behave and interact with FDA inspectors can have an impact on the results reported.  Interacting with inspectors is not a natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.

This 3-hour webinar presented over two days will provide this knowledge and audit preparation readiness.

Who Should Attend:-

This is an all-inclusive seminar benefiting all individuals within the organization particularly those in positions of management and supervision. Vice Presidents, Directors, Associate Directors, Managers, and Supervisors in ALL functions will benefit from this organization. Significantly, compliance and regulatory who spearhead the inspections and are responsible for compliance readiness, as well as training that should be building on-going training around this subject should also be included.