• Sep 25, 2023 from 1:00 to 2:15
  • Location: Online Event
  • Latest Activity: Sep 18, 2023

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.

AREA COVERED

  • 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

LEARNING OBJECTIVES

  • 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?

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

 

https://247compliance.us/fda-current-recommendations-related-to-timely-initiation-of-and-responses-to-recalls/2009?through=RuthMartine_18thSEPTEMBER_IN&sm_GRC

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