6-Hour Virtual Seminar
6-Hour Virtual Seminar on Successfully Preparing for, Conducting, and Executing an FDA Audit of your Operations
- Wednesday
- September
- 18
- 2024
Time:
08:00 AM PDT | 11:00 AM EDT
Duration:
6 Hours
Webinar Id:
53144
More Trainings by this Expert
Price Details
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Overview:
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 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
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.
Agenda:
I. Setting the Stage
- FDA Inspection Operations - how they do it
- Risk-Based approaches for priotizing sites for GMP Inspection
- ICH Q9/Q10
- Types of Inspections
- Pre-Approval
- Post-Approval
- Product Survelliance
- 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
- Inspection considerations
- Medical devices
- Drug production
- Clinical trials
II. 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
- Inside the mind of an FDA investigator
- 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't's
Who Will Benefit:
- 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