Registration & Listing, FDA Inspection Strategies and Compliance Initiatives – Medical Device

Larry-Spears
Speaker: Larry Spears
Principal Consultant, Regulatory Affairs & QuCertified Compliance Solutions, Inc.
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Date: January 3rd Tuesday
Time: 01:00 PM EST | 10:00 AM PST
Duration: 60 Minutes
Product Code: 300017
Level: Beginner
Key Take Away

An opportunity to better understand how FDA thinks and operates and what their key areas of focus and priority are, from a former Compliance insider.

Overview

Have you ever wondered about the FDA strategies for scheduling inspections and pursuing compliance plans?  This seminar will provide clarity around those issues from a compliance expert with over 30 years’ experience in inspection and compliance management.

why should you attend

Many companies do not know what they don’t know when it comes to dealing with the FDA. By not understanding how FDA uses registration and listing data, these companies sometimes fail to address key issues in response to fda 483s and Warning Letters and fail to manage inspections to reduce their overall risk. Here is your chance to better understand how FDA thinks and operates and what their key areas of focus and priority are from a former Compliance insider.

Areas Covered in this Webinar

Registration and Listing regulatory requirements, process, and how FDA uses this data will be discussed. FDA strategic direction and how they reach decisions in developing inspection and compliance plans will be discussed.


Learning Objectives
  • Registration and Listing process and requirements.
  • FDA inspection planning activities 
  • Compliance strategies

Who Will Benefit
  • VP’s and Directors in Regulatory Affairs 
  • VP’s and Directors in Quality Assurance
  • Regulatory Affairs Managers and Professionals
  • Quality Managers and Professionals
  • Small Business Owners
Speakers Profile
Larry Spears

Larry Spears has deep regulatory expertise from over 35 years' experience in government and consulting. This includes investigations, compliance and regulatory roles with FDA including senior compliance leadership positions in the CDRH Office of Compliance, as a consultant with a large life sciences consulting firm and as an independent consultant. Mr. Spears provides global regulatory strategy consultation to Life Science companies primarily in medical devices/diagnostics and pharmaceuticals with a focus on quality systems gap assessments, FDA mock inspections, quality system development and planning, and remediation for FDA inspection findings including, CAPA and complaints, design controls, supplier controls, production management, and training

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