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. (see
full course description)
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Training Course
Syllabus:
Why is FDA at my facility, and what do I do during an inspection?
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.
Course
Outline:
Day One (8:30 AM – 5:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
FDA Law and Inspection Training
FDA Management and General Training
Legal Obligations
FD&C Act, § 704(a)(1), Right to Inspect
Case Law- Real life examples
Section 305 Notices
Indictments
Convictions
Debarment
Consent Decree
Dis-engorgement penalty
Regulatory Sanctions used by FDA
Written Notices
Judicial Action
Prosecution (fines, jail)
Administrative Action
Prohibited Acts
Interstate commerce
Adulteration
Misbranding
Penalties
Seizure
Injunction
Prosecution (fines, jail)
Civil vs. Criminal
Management Responsibility from FDA’s view
Management with Executive Responsibility defined
Expectations
Resources
Duty, Power, Responsibility
Front Room Back Room
Your FDA Inspection Team
Inspection Team Roles
Assigning jobs on the Inspection Team
FDA Inspection SOP
Initial FDA Meeting
Scribes-what are they – what do they do?
Runners- 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, 483/Warning Letter Response
SME Training
Basic Ground Rules for everyone
Role of the SME
What is an SME?
SME Characteristics
How to choose effective SMEs
Off-site SMEs
SME’s Should:
Utilize Subject Matter Experts (SMEs)
FDA Interviews
predetermined roles
How to understand and answer FDA questions
Should you use props!
What does your Facilitator do?
How to get the best out of the inspection
Say NO to…
Do’s and Don’ts
Replying to 483s and Warning Letters
General Points to Consider
FDA 483 Responses
Warning Letter Responses
What you must know about both responses
Hard copy or via the internet?
Specific and Systemic Corrections
Templates to consider
Make sure…
The Response
Response Cover Letter Importance Tone Who Signs
Response Body
Attachments
Templates
Let’s not forget
When and How to do updates
Seminar Summary:
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. (see
full course description)
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