Why is FDA at my facility, and what do I do during an inspection?: 2-day In-person Seminar

By: Stephanie Harrell, Consultant, ProPharma Group
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Course Description:

This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SME’s) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.

This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records. We cover do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. We provide tips for Executive Management/CEO’s, Production area staff, Reception Area staff and what each group needs to know during an inspection. The session includes real life inspection scenarios/case studies. Participants are given real life FDA inspection scenarios and are asked to discuss how they would handle each situation. Feedback is given on how to best handle each situation and scenario. This is one of our most popular training sessions!

Learning Objectives:

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:

  • Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
  • What to do when FDA knocks – step by step instructions to handle inspections.
  • How to handle day by day inspection scenarios?
  • What is a front room and back room? Do you need one?
  • Runners and Scribes? What do they do?
  • Are your SME’s the right people, and are they ready/right for the job?
  • Why responses to 483’s and Warning Letters are critical?
  • Steps for responding to 483’s and Warning Letters.

Who will Benefit:

Industries Positions/Titles Types of facilities:
  • FDA regulated Industries
    • Medical Device
    • Pharmaceuticals
  • Dietary Supplements
    • Food
    • Med Tech
  • Top and Middle Management
  • Subject Matter Experts (SME)
  • Quality Assurance/management
  • Compliance Management
  • Manufacturing
  • Laboratory
  • Regulatory Personnel
  • Manufacturing facilities
  • Private label and contract manufacturing facilities
  • Distributors, warehouses
  • Own label distributors, private label distributors
  • Packers, Labelers
  • Ingredient suppliers
  • Laboratories
  • Importers

Course Outline

Day One (8:00 AM – 4:30 PM)
  • Legal Obligations
  • FD&C Act and 704(a)(1), Right to Inspect
  • Case Law - Real Life Examples
    • Indictments
    • Convictions
    • Consent Decree
    • Injunctions
  • Administrative Action Tools-
    • Inspections
    • Notice of Violations
    • 483’s
    • Warning Letters
  • Prohibited acts
    • Adulteration
    • Misbranding
  • FDA Enforcements
    • Seizures
    • Civil vs. Criminal
  • Management Responsibility from FDA’s View
    • Management with Executive Responsibility defined
    • Expectations
    • Resources
    • Duty, Power, Responsibility
  • Front Room / Back Room Preparation
    • Inspection Team Roles
    • Assigning Jobs on the Inspection Team
  • FDA Inspection
    • Initial FDA Meeting
    • Scribes – What Are They / What Do They Do?
    • Runners – What Are They / What Do They Do?
    • Recorders – What Are They / What Do They Do?
    • Reviewers – What Are They / What Do They Do?
  • Front Room / Back Room
    • Staffing
    • Supplying / Equipping
    • Location
    • Training / Prep
  • Putting It All Together
  • Day Two (8:30 AM – 4:30 PM)
  • SME Training and FDA-483’s / Warning Letter Responses
  • Role of the SME
    • Who Is A SME?
    • What Are SME Characteristics
    • How To Choose Effective SME’s
    • SME’s Should…?
    • When To Use Subject Matter Experts (SME’s)
  • FDA Interviews
    • Predetermined Roles
    • How To Understand and Answer FDA Questions
    • What Does Your Facilitator Do?
  • How To Get The Best Out of The Inspection
    • Say NO to…
    • Do’s and Don’ts
  • Replying to FDA-483’s and Warning Letters
    • General Points to Consider
    • FDA-483 Responses
    • Warning Letter Responses
    • What You Must Know About Both Responses
    • Hard Copy vs. via the Internet?
    • Specific and Systemic Corrections
  • The Response
    • Response Cover Letter Importance Tone – Who Signs?
    • Response Body
    • Attachments?
    • Let’s Not Forget…
    • When and How To Do Updates
  • Meet Your Instructor

    Stephanie Harrell
    Stephanie Harrell
    Consultant, ProPharma Group

    Stephanie Harrell, B.S. has more than 13 years of experience in combined Food and Drug Administration (FDA) regulated industry inspections and consulting with experience in both the pharmaceutical and medical device industries including supplier audits. Ms. Harrell has both conducted and provided training on such topics as managing quality systems, regulatory inspections and audit preparation. She is an ex FDA investigator and speaker at numerous FDA regulated industry conferences. She also has an extensive background which includes healthcare industry consulting and training. Stephanie is passionate about contributing her knowledge to companies for the preparation skills needed for FDA inspections and has a teaching style that is interactive to bring the information to life and help learners generalize information across their various roles and jobs.

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    It was a lively seminar with good real life examples and case studies. Management responsibility topic was most valuable for me because it is often missed and not addressed in other seminars. I really appreciate the way how GRC Seminars is conducting seminars and webinars. Their training topics are always current and timely.
    - Quality Assurance Manager, Nellson Nutraceutical

    I like the way how seminar was informal and allowing for dialogue. We discussed practical inspection situations through class questions and case studies which will help organizations prepare for inspections. GRC Seminars has chosen a great venue for this seminar.
    - Quality Assurance Specialist, Gilead Sciences

    I really enjoyed both presenters and their field experience was shown throughout the session that was very helpful. It provided good insight in the proper demeanor to have while dealing with the FDA auditors on site.
    - Quality Assurance, Paramount Farms International, LLC

    This seminar provided a good understanding on FDA systems and also provided awareness on compliance issues. Case studies discussed were very useful. This seminar was well coordinated by GRC Seminars and had a very professional approach on the entire process.
    - Cody Laboratories

    This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.
    - Director of QC and Food Safety, Dulcinea Farms, LLC

    Martina and Shelly are very knowledgeable and as former investigators have provided valuable information and insight. Front/back room set up topic was highly valuable to me because we have an upcoming PAI and this information will help us to prepare upfront.
    - QA Manager, Trius Therapeutics

    This seminar was incredibly informative and there was a good amount of interaction between the speakers and the participants. Both the instructors were highly knowledgeable and experienced and I liked their rapport with each other. Also the case studies discussed were very useful.
    - Sr. QA Associate II, Ardea Biosciences

    Interaction among attendees and the presenters was excellent. Gained good insight on how to respond to FDA warning letters and 483s. It was a well-organized event. I am impressed with the way how GRC Seminars has conducted this seminar.
    - Supervisor, Corporate Audit, Apotex Inc.

    This was an interesting session with good practical information. Case studies discussed are very useful to me.
    - Director Quality Assurance, Cereal Ingredients, Inc

    It was an excellent resource for those companies starting the journey of preparation for FDA audits.
    - Quality Assurance, Paramount Farms International, LLC

    Presenters were highly knowledgeable and conversation with other participants were very beneficial for me.
    - Quality Manager, Cereal Ingredients, Inc

    I thoroughly enjoyed this session. Instructors provided good real life examples and personal experiences.
    - Quality Assurance, Paramount Farms International, LLC

    Seminar was very helpful and both the presenters were highly knowledgeable.
    - Chief Engineer, Terumo Corporation

    It was valuable to have training from experienced and highly knowledgeable former FDA investigator and compliance officer.
    - Program Manager, Medtronic

    I really enjoyed this seminar and it was covering a wide range of topics for various industries.
    - QA Manager, Trius Therapeutics

    I learned a lot about process during the FDA audits, FDA's expectations and how to prepare for the audits. Good stories and experiences shared by presenters were very interesting and it was a nice team teaching method.
    - Food Safety Supervisor, Paramount Farms

    Excellent and highly knowledgeable speakers with great new ideas and approaches.
    - Sr. Manager – QA, Trius Therapeutics

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