Managing FDA Inspections from Readiness through Follow Up Responses
Jonathan M. Lewis, Founding Partner, Reliant FDA Experts™…a Division of Advanced Biomedical Consulting, LLC
Coming soon.. Please contact customer care for new schedule
||Course "Managing FDA Inspections from Readiness through Follow Up Responses" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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.
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:
USB with seminar presentation
Hard copy of presentation
$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
- 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)
- Brief Background and History of FDA (45 Minutes)
The Law (30 Minutes)
- Brief history of FDA
- Regulatory references
Why Is FDA Inspecting Us? (30 Minutes)
- What is the law?
- What are the regulations?
- What gives FDA the right to inspect?
Who are the Inspectors? (1 Hour)
- Types of facilities within scope
- Exempt facilities
- Reasons for inspections
Preparing for an Inspection (1.5 Hours)
- An individual or a team?
- The typical investigator “Specs”
- The mind of an investigator
- The inspector’s goals
Managing the Inspection (2 Hours)
- Essential documentation collection
- The SOP
- Mock inspection
Potential Outcomes of an Inspection (1 Hour)
- FDA is here!
- What to ask
- What to tell
- How to manage documentation requests
- Diffusing situations
Responding to 483s and Warning Letters (1.5 Hours)
- Warning letters
- Consent decrees
Post Response Activities (30 Minutes)
- The Concept
- To whom to send the written response
- CAPA concept
- Supporting documentation
- Sample 483 responses
Day 1 Closing Comments and Questions (30 Minutes)
- Additional correspondence
- Meetings with FDA
- Verification activities
Welcome and Day 1 Reinforcement (15 Minutes)
- Practical Application # 1 – Practical Exam (1 Hour)
- Practical Application # 2 – 483 Response (2 Hours)
- Closing Comments (15 Minutes)
- 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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Palo Alto, CA 94303
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