The FDA Inspection Process: From SOP to 483

Speaker

Instructor: Jeff Kasoff
Product ID: 700269
Training Level: Intermediate

Location
  • Duration: 60 Min
This is a detailed course designed to provide 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: Sep-2018

 

$299.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
1 USB is for usage in one location only. info CD/USB and Ref. material will be shipped within 15 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

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Why You Should Attend:

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 Webinar:

  • Types of Inspections
  • Preparation
    • Dedicated personnel for inspection
    • Facility resources to support the inspection
    • Internal audits
  • SOP for inspections
  • Behaviour 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
    • Quality Control
    • Product Development
    • Engineering;
    • Manufacturing
    • Risk Management
  • 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 of experience 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 start-up 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. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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