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.
WHY SHOULD YOU ATTEND?
When a recall is needed, do you know what your responsibilities are regarding initiation/ notification? Whether you are a manufacturer or a distributor, it is important to understand FDA expectations and requirements when reporting the recall to the industry. You should also be aware of the processes you should have when you receive a recall notification. This course will help you identify what internal processes should be established within your facility.
- Overview of Recall Terminology
- Preparation firms in a distribution chain should consider initiating 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
- 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.
WHO WILL BENEFIT?
- QA/QC staff
- Regulatory affairs professionals