Recall Management - Regulations and System Requirements
Instructor:
David Husman
Product ID: 706622
Training Level: Moderate
- Duration: 60 Min
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
David Husman
President and Principal Consultant, David Husman Consulting LLC
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