FDA current recommendations related to timely initiation of and responses to recalls

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.

• 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

• 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

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.

• Supervisors
• Managers
• Directors
• QA/QC staff
• Regulatory affairs professionals
• Manufacturers
• Distributors 
• CMO’s

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.