This seminar is broken into two phases. Phase one corresponding to Day 1 will build basic knowledge of the inspection - the who, what, and when. Phase Two corresponding to Day 2 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 communications 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.
WHY YOU SHOULD ATTEND:
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 and an unsuccessful FDA audit. The cost of an ineffective interaction can be staggering.
If you are in any regulated business - pharmaceuticals, 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 upon 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 an natural behavior, effective techniques must be learned and mastered if those inspections are to have positive outcomes.
Course Content
DAY 1 (11 AM to 3 PM)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
Preparation, Inspection Conduct and Do’s and Don’ts
- The FDA Investigator
- Preparation
- General
- 3I approach of Implement-Inspect-Incorporate
- Gap analysis and root cause determination
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
- Current Good Manufacturing Practice (cGMP)
- General FDA Inspection Protocol
- What is covered during a routine inspection
- Inspection conduct
- Importance of truthfulness
- Importance of knowledgeability and confidence
- FDA Tricks to elicit information
- Arguing and challenging
- Behavior during the inspection
- Importance and role of documentation
- Effective communication skills
- Being deceptive
- Opinion versus fact
- Phrases never to say
- Handling adverse findings during the inspection
- Inspection Do’s and Don’ts
Speakers
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.
