DUBLIN--(BUSINESS WIRE)--The "Why is FDA at my facility, and what do I do during an inspection?" conference has been added to ResearchAndMarkets.com's offering.
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!
- 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 Should Attend:
FDA regulated Industries
- Medical Device
- Med Tech
- Top and Middle Management
- Subject Matter Experts (SME)
- Quality Assurance/management
- Compliance Management
- Regulatory Personnel
- Manufacturing facilities
- Private label and contract manufacturing facilities
- Distributors, warehouses
- Own label distributors, private label distributors
- Packers, Labelers
- Ingredient suppliers
FD&C Act and 704(a)(1), Right to Inspect
Case Law - Real Life Examples
- Consent Decree
Administrative Action Tools
- Notice of Violations
- Warning Letters
- Civil vs. Criminal
Management Responsibility from FDA's View
- Management with Executive Responsibility defined
- Duty, Power, Responsibility
Front Room / Back Room Preparation
- Inspection Team Roles
- Assigning Jobs on the Inspection Team
- 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
- Supplying / Equipping
- 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)
- 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
- Response Cover Letter Importance Tone - Who Signs?
- Response Body
- Let's Not Forget
- When and How To Do Updates
For more information about this conference visit https://www.researchandmarkets.com/r/ivmo9q