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Recall Management - Regulations and System Requirements
- 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

David Husman
President and Principal Consultant, David Husman Consulting LLC
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Refund Policy
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.
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