Course Description:

This two day interactive course will prepare firms for a quick, productive, and efficient FDA inspection. It includes 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. The session includes real life inspection scenarios/case studies and templates.

Day one of the seminar will begin 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, instructor will 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. On day two, instructor will focus on do’s and don’ts, choosing your core inspection team, facilitators, Subject Matter Experts (SME’s), runners and scribes. This course also provides tips for executive management/CEO’s, production area staff, reception area staff and what each group needs to know during an inspection.

Participants will be getting real life FDA inspection scenarios and will be asked to discuss how they would handle each situation. Feedback will be given on how to best handle each situation and scenario. This is one of our most popular training sessions!

Seminar instructor Shelly Maifarth is an ex-FDA official having more than 30 years of experience working with the FDA as an investigator, microbiologist and as a compliance officer.

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
    • Pharmaceuticals
    • Medical Device
    • Food & Dietary Supplements
    • 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 (8.30AM – 5.00PM) Day Two (8.30AM – 5.00PM)

FDA Law and Inspection Training

  1. FDA Management and General Training
    1. Legal Obligations
      1. FD&C Act, § 704(a)(1), Right to Inspect
      2. Case Law- Real life examples
        1. Section 305 Notices
        2. Indictments
        3. Convictions
        4. Debarment
        5. Consent Decree
        6. Dis-engorgement penalty
      3. Regulatory Sanctions used by FDA
        1. Written Notices
        2. Judicial Action
        3. Prosecution (fines, jail)
      4. Administrative Action
      5. Prohibited Acts
        1. Interstate commerce
        2. Adulteration
        3. Misbranding
      6. Penalties
        1. Seizure
        2. Injunction
        3. Prosecution (fines, jail)
      7. Civil vs. Criminal
    2. Management Responsibility from FDA’s view
      1. Management with Executive Responsibility defined
      2. Expectations
      3. Resources
      4. Duty, Power, Responsibility
  2. Front Room Back Room
    1. Your FDA Inspection Team
      1. Inspection Team Roles
      2. Assigning jobs on the Inspection Team
    2. FDA Inspection SOP
      1. Initial FDA Meeting
      2. Scribes-what are they – what do they do?
      3. Runners- what are they- what do they do?
    3. Front Room/Back Room
      1. Staffing
      2. Supplying/equipping
      3. Location
      4. Training/Prep
    4. Putting it all together

SME training, 483/Warning Letter Response

  1. SME Training
    1. Basic Ground Rules for everyone
    2. Role of the SME
      1. What is an SME?
      2. SME Characteristics
      3. How to choose effective SMEs
      4. Off-site SMEs
      5. SME’s Should:
      6. Utilize Subject Matter Experts (SMEs)
    3. FDA Interviews
      1. predetermined roles
      2. How to understand and answer FDA questions
      3. Should you use props!
      4. What does your Facilitator do?
    4. How to get the best out of the inspection
    5. Say NO to…
    6. Do’s and Don’ts
  2. Replying to 483s and Warning Letters
    1. General Points to Consider
      1. FDA 483 Responses
      2. Warning Letter Responses
      3. What you must know about both responses
      4. Hard copy or via the internet?
      5. Specific and Systemic Corrections
      6. Templates to consider
      7. Make sure…
    2. The Response
      1. Response Cover Letter
        1. Importance
        2. Tone
        3. Who Signs
      2. Response Body
      3. Attachments
    3. Templates
    4. Let’s not forget
    5. When and How to do updates

* This training will not delve into clinical inspection issues.

Meet Your Instructor

Shelly Maifarth, RAC
Principal, FDA Compliance Group LLC

Shelly Maifarth began her career with FDA as an investigator and microbiologist in Dallas and Denver Districts from 1972 to 1984, then served as an FDA Compliance Officer in Denver's District Office for more than 22 years. As a compliance officer, she has significant experience in the medical device, dietary supplement, food, and pharmaceutical areas. She has conducted training, reviewed quality systems and provided guidance on quality, labeling and compliance issues. Ms. Maifarth provided technical assistance and guidance to investigators and analysts within Denver District, and to state, local, and other federal agencies, including Customs (CBP), EPA, and CDC.

As the senior Compliance Officer in the Denver District Office, Ms. Maifarth received the most complex cases to determine if a company was in compliance with FDA laws, regulations and current policy. These cases were in the areas of medical device cGMPS/labeling/510(k)/PMA, dietary supplement labeling, pharmaceutical GMPS/labeling/new drug, seafood and juice HACCP, and food sanitation and labeling. She successfully completed numerous regulatory actions to bring firms and products into compliance. These actions included Warning Letters, Regulatory Letters, Seizures, Injunctions, Prosecutions, Inspection Warrants, License Suspensions and License Revocations. She provided guidance to assist these companies to come into compliance after these FDA actions.

Ms. Maifarth served as a member of the Expert Panel for National Compliance Officers Law Course, a member of Cadre and Trainer for National Compliance Law Clerk Course, and has provided training for Regulatory Affairs Professional Society (RAPS) on current FDA compliance policies on dietary supplements, drugs and medical devices.

Since beginning her career as a consultant, she has worked extensively with medical device and dietary supplement industries to assist them in achieving compliance with the requirements of FDA laws and regulations. She has coordinated meetings and successfully interacted with FDA on behalf of client firms at the Denver District, FDA Headquarters, and other district offices. She effectively coordinates communication with FDA post-audit, writes 483 responses on behalf of client firms to the FDA, and coordinates any subsequent follow-up.

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