6-Hour Virtual Seminar

6-Hour Virtual Seminar on Successfully Preparing for, Conducting, and Executing an FDA Audit of your Operations

Product Id : 12363
Charles H. Paul
6 Hours
Charles H. Paul

Price Details +

US$495.00 Recorded
US$845.00 Corporate Recorded
Refund Policy

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.

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

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

Speaker Profile


Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, manufacturing, training, and technical documentation consulting firm – celebrating its twentieth year in business in 2017. Charles has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.

He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc.. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.

He has dedicated his entire professional career explaining the benefits of performance-based training