Course Description:

If you are looking for answers to these questions, you would certainly benefit by attending this seminar on managing FDA inspections:

  • Has your company ever been unprepared for an FDA inspection?
  • How should one respond to a 483 or warning letter correctly the first time without hiring a costly law firm?
  • What the agency can and cannot ask for during an inspection?

Well, the answers to these and many, many more typical questions are now available in a simple to understand yet detailed training session designed to help manufacturers of FDA regulated products prepare for, manage, and follow up on inspections.

Learning Objectives:

This course on managing FDA inspection will:

  • Define the steps necessary to prepare for an FDA inspection
  • Discuss details surrounding the management of inspections from announcement to close out meeting
  • Offer responses to FAQs regarding typical inspector requests during inspections
  • Define the methodology for responding to 483 and warning letters
  • Offer templates for response letters
  • Discuss common pitfalls to avoid during an inspection

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course will provide valuable assistance and guidance to all regulated companies (pharmaceutical, biopharmaceutical, biologics, medical device etc) that are preparing for FDA inspections. The following job titles/ positions will benefit from attending this seminar:

  • Internal Auditors
  • Regulators
  • Legal Departments
  • Compliance Officers
  • Validation Managers
  • QC Managers
  • QA Managers
  • Facilities and Engineering Department Staff
  • Compliance Consultants
  • Senior Management

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 1:00 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Welcome and Introductions (15 Minutes)

  1. Brief Background and History of FDA (45 Minutes)
    • Brief history of FDA
    • Regulatory references
    • Terminology
  2. The Law (30 Minutes)
    • What is the law?
    • What are the regulations?
    • What gives FDA the right to inspect?
  3. Why Is FDA Inspecting Us? (30 Minutes)
    • Types of facilities within scope
    • Exempt facilities
    • Reasons for inspections
  4. Who are the Inspectors? (1 Hour)
    • An individual or a team?
    • The typical investigator “Specs”
    • The mind of an investigator
    • The inspector’s goals
  5. Preparing for an Inspection (1.5 Hours)
    • Essential documentation collection
    • The SOP
    • Mock inspection
  6. Managing the Inspection (2 Hours)
    • FDA is here!
    • What to ask
    • What to tell
    • Tours
    • How to manage documentation requests
    • Diffusing situations
    • Closeout
  7. Potential Outcomes of an Inspection (1 Hour)
    • 483s
    • Warning letters
    • Consent decrees
  8. Responding to 483s and Warning Letters (1.5 Hours)
    • The Concept
    • To whom to send the written response
    • Format
    • Commitment
    • CAPA concept
    • Supporting documentation
    • Sample 483 responses
  9. Post Response Activities (30 Minutes)
    • Additional correspondence
    • Meetings with FDA
    • Verification activities
  10. Day 1 Closing Comments and Questions (30 Minutes)

Welcome and Day 1 Reinforcement (15 Minutes)

  1. Practical Application # 1 – Practical Exam (1 Hour)
  2. Practical Application # 2 – 483 Response (2 Hours)
  3. Closing Comments (15 Minutes)
  4. Individual/Open Q&A Session (30 Minutes)

Meet Your Instructor

Jonathan M. Lewis
Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC

Jonathan M. Lewis, founding partner, Reliant FDA Experts™ - a division of Advanced Biomedical Consulting, LLC, has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), regulatory affairs, manufacturing, validation, project management, and executive management in both the industry and in consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal food industries.

Prior to founding Reliant FDA Experts™, Mr. Lewis worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level validation engineer to the associate director of consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/validation manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, as a sterility assurance laboratory technician.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee an electronic event pass will be sent to the email address associated with the registrant before 5 working days from the seminar date. Please bring the pass to the venue of the event.

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