Recall Management - Regulations and System Requirements

Speaker

Instructor: David Husman
Product ID: 706622
Training Level: Moderate

Location
  • Duration: 60 Min
The purpose of this presentation is to provide an overview of the regulations and guidance applicable to managing Recalls of drugs, biologics and devices in the United States. It will describe the quality management system components that are necessary for supporting recalls and encourage you to prepare for a recall well in advance of any actual need to execute a recall.
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Why Should You Attend:

As FDA has the authority and obligation to protect the American consumer from products that may be violative or unsafe, it is incumbent upon companies and their management to understand what is involved in a recall and also to develop processes to both execute a mandatory recall as well as how to voluntarily withdraw products from the market either via a market withdrawal action of execution of a recall. This webinar will discuss the regulations and the systems necessary to determine if a recall is required and to execute one should it be necessary.

Recalls can be highly disruptive to a company’s operations. If you are not prepared for what is required and how to executed a recall you could find the disruption becomes long lasting and highly expensive. This presentation will provide an overview of the requirements for performing a recall and also a translation of these regulations into quality management system requirements. Additionally, it will provide a high-level process flow preparation and for execution of a recall.

Areas Covered in the Webinar:

  • Regulation
    • 21 CFR 7.41-7.59
  • Guidance
    • Product Recalls, Including Removals and Corrections Guidance for Industry March 2020
  • Example of Scope and breadth of company impact
  • System Requirements
    • Procedures
    • Tools
    • Execution Process
  • High Level Process Flow
    • Preparation
    • Decision Making
    • Execution

Who Will Benefit:

  • Quality Assurance Management.
  • Personnel responsible for executing and managing recall activities, including communication with regulatory authorities
  • Executive Management

Free Materials:

  • Sample SOP – Test Execution and Review
Instructor Profile:
David Husman

David Husman
President and Principal Consultant, David Husman Consulting LLC
  • Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.
  • Experience has spanned from R&D to Commercial Manufacture
  • Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.
  • Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.
  • Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.
  • Expert level in Compliance and Quality System development.
  • Executed numerous Data Integrity assessments and remediation projects worldwide.
  • Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.
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