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

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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