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:
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- 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
- 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
Stephanie Harrell
Consultant, ProPharma Group
(Ex-FDA Investigator)
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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Quality Assurance Manager,
Nellson Nutraceutical
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Gilead Sciences
Quality Assurance,
Paramount Farms International, LLC
Cody Laboratories
Director of QC and Food Safety,
Dulcinea Farms, LLC
QA Manager,
Trius Therapeutics
Sr. QA Associate II,
Ardea Biosciences
Supervisor,
Device Manufacturing, Vital Therapies
Director Quality Assurance,
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Quality Assurance,
Paramount Farms International, LLC
Quality Manager,
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Quality Assurance,
Paramount Farms International, LLC
Chief Engineer,
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Program Manager,
Medtronic
QA Manager,
Trius Therapeutics
Food Safety Supervisor,
Paramount Farms
Sr. Manager – QA,
Trius Therapeutics
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