The FDA Inspection: Best Practices for Preparation, Management, and Follow-Up

Speaker

Instructor: Jeff Kasoff
Product ID: 701568
Training Level: Intermediate to Advanced

Location
  • Duration: 60 Min
This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.
RECORDED TRAINING
Last Recorded Date: Feb-2015

 

$229.00 $299.00 (23%)SAVE: $70.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
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$399.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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Why Should You Attend:

Without adequate preparation and cross-functional communication, it is difficult to manage a good FDA inspection. Your goal is to illustrate your firm is in substantial compliance with all regulations, but also to respond to the inspector’s questions or concerns in a timely manner. This webinar will identify systems and processes, and recommended tactics, to make the inspection as painless as possible.

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Areas Covered in the seminar:

  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
  • SOP for inspections
  • Behavior during inspection: What to say and do, and what NOT to say and do
  • Inspection process
  • How and when to craft a written response

Who will benefit:

This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Quality Auditors
  • Compliance Officers
  • Executive Management
  • Managers/Directors/Supervisors and Personnel related to:
    • Regulatory Compliance and Regulatory Affairs;
    • Quality Management System;
    • Quality Assurance;
    • Product Development;
    • Engineering;
    • Manufacturing;
  • Complaint Handling
  • Personnel new to the regulated industry
  • Training personnel
  • Document Control Personnel
Instructor Profile:
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

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