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

We all shudder to say that dreadful “R” word.  Recalls are costly and time-consuming to any organization, whether a manufacturer or distributor.  Whether the facility is the initiator or required to respond. Therefore, some organizations tend to delay the initiation of a recall or fail to respond to one.  The FDA recently published a Guidance Document to provide clarification to the FDA’s recommendations/ expectations when it comes to Recalls, press releases, or other public notifications that could impact public health and safety.

• Define a recall and other terminology related to a recall.
• Describe when a recall is required.
• What processes need to be implemented to ensure the timely initiation of a recall?
• Identify internal processes to implement to ensure timely recall responses.
• Understand how the FDA will assist your facility with carrying out recall responsibilities.

• Overview of Recall Terminology
• Preparations firms in a distribution chain should consider making to initiate a recall. 
• Steps to take to ensure timely identification of and response to product problems that might lead to a Recall
• Timely Initiation of recall communications
• Preparations a firm should take to respond to a recall in a timely manner.
• When is a recall necessary?
• Working with the FDA on recalled products

When a recall is needed, do you know what your responsibilities are when it comes to initiation/ notification?  Whether you are a manufacturer or a distributor, it is important to understand FDA expectations and requirements when it comes to reporting the recall to the industry.  You should also be aware of what processes you should have in place when you receive a recall notification. This course will help you identify what internal processes should be established within your facility.

• 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.