Best Practices for FDA Inspection: Do's and Don'ts

OVERVIEW:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

 

This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome. This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.
Time: 9:00 AM to 6:00 PM
Who Will Benefit:
This seminar will provide valuable assistance and guidance to all regulated companies that are preparing for FDA inspections. The employees who will benefit include:

• All levels of Management for all departments
• QA/QC/Compliance/Regulatory Affairs
• Information Technology/Marketing & Sales
• Engineering/Technical Services/Validation
• Consultants
• Operations and Manufacturing

AGENDA:
Day 1 Schedule:

Lecture 1: How a firm should prepare for an FDA inspection
Lecture 2: Ways to train employees in view of the inspection
Lecture 3: How to ensure that required documentation is in place
Lecture 4: How to interact with the investigator-DO and DON'T's
Lecture 5: What companies should do when the inspection ends
Lecture 6: How to reply to 483's and warning letters
Lecture 7: Legal implications of non-compliance
Lecture 8: Post inspection actions

Day 2 Schedule:

Lecture 1: Why inspections are conducted and by what statutory authority
Lecture 2: The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Lecture 3: What is subject to FDA purview and what's off-limits
Lecture 4: Understand and apply the do's and don'ts and comprehend that preparation is the key to success
Lecture 5: What are the prohibited "Acts" and the enforcement categories that you need to deal with
Lecture 6: What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
Lecture 7: the Company’s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Lecture 8: How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development

Others Details

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