Recalls are costly and time-consuming for manufacturers and distributors alike, whether you start the recall or have to respond to one. That is why some firms delay initiating a recall or fail to respond. FDA has published guidance clarifying its expectations for recalls, press releases and other public notifications that affect public health and safety.
This 75-minute FDA recall training walks through that guidance. You'll review recall terminology, when a recall is necessary, and what firms in the distribution chain should do in advance to initiate a recall. The session covers steps to spot product problems early, timely recall communications, preparing to respond quickly to a recall notice and working with FDA on recalled products.
WHY SHOULD YOU ATTEND?
When a recall is needed, manufacturers and distributors must know their responsibilities for initiation and notification and have processes ready for when a recall notice arrives. This session helps you identify the internal processes your facility should set up.
It suits supervisors, managers, directors, QA/QC staff, regulatory affairs professionals, manufacturers, distributors and contract manufacturing organizations.
AREA COVERED
- Recall terminology
- Preparations firms in a distribution chain should make to initiate a recall
- Steps for timely identification of and response to product problems that might lead to a recall
- Timely initiation of recall communications
- Preparations for responding to a recall in a timely manner
- When a recall is necessary
- Working with FDA on recalled products
LEARNING OBJECTIVES
- Define a recall and related terminology
- Describe when a recall is required
- Put processes in place for timely recall initiation
- Identify internal processes for timely recall responses
- Explain how FDA can help your facility carry out recall responsibilities
WHO WILL BENEFIT?
- Supervisors
- Managers
- Directors
- QA/QC staff
- Regulatory affairs professionals
- Manufacturers
- Distributors
- CMO’s
When a recall is needed, manufacturers and distributors must know their responsibilities for initiation and notification and have processes ready for when a recall notice arrives. This session helps you identify the internal processes your facility should set up.
It suits supervisors, managers, directors, QA/QC staff, regulatory affairs professionals, manufacturers, distributors and contract manufacturing organizations.
- Recall terminology
- Preparations firms in a distribution chain should make to initiate a recall
- Steps for timely identification of and response to product problems that might lead to a recall
- Timely initiation of recall communications
- Preparations for responding to a recall in a timely manner
- When a recall is necessary
- Working with FDA on recalled products
- Define a recall and related terminology
- Describe when a recall is required
- Put processes in place for timely recall initiation
- Identify internal processes for timely recall responses
- Explain how FDA can help your facility carry out recall responsibilities
- Supervisors
- Managers
- Directors
- QA/QC staff
- Regulatory affairs professionals
- Manufacturers
- Distributors
- CMO’s