FDA current recommendations related to timely initiation of and responses to recalls
Learn when a recall is needed, how to prepare to initiate or respond to one quickly, and what FDA expects from manufacturers and distributors in recall communications.
Speaker
Meredith Crabtree
Quality consultant · 25+ years in regulated industries
Overview
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 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.
What’s 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
Who should attend
What you get
About the speaker
Meredith Crabtree has over 25 years’ experience in regulated industries, ranging from Blood, Plasma, Tissue, Laboratory, Pharma, Medical devices, Cosmetics, Supplements, and Animal Health manufacturing and distribution. Meredith works as a Quality Consultant performing label reviews, 3rd party inspections, Consent Decree, and Recall support. She also performs regulatory assessments and Quality training. Meredith has a degree in Medical Technology and is currently obtaining a degree in Quality Systems.
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