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 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.
AREA COVERED
- 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
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
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.
- 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
- 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.
- Supervisors
- Managers
- Directors
- QA/QC staff
- Regulatory affairs professionals
- Manufacturers
- Distributors
- CMO’s
Speaker Profile

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.
Upcoming Webinars


Stop Letting that Difficult Person Ruin your Day - Effectiv…

FDA's Technology Modernization Action Plan (TMAP) And Impac…

Nailing the Candidate Experience, Attracting Talent



Developing and Implementing Inclusive Leadership Strategies

Supervising a Human Error Free Environment: You can do a Lo…

Improving Organizational Performance through Enhanced Emplo…

Creative Leadership through Emotional (EQ) and Humor (HQ) I…

FDA's new Cosmetic labeling requirements

New Announcement! DHS Terminates The I-9 Form Remote Option…

Why EBITDA Doesn't Spell Cash Flow and What Does

Faster Payments in Today's World - Details on the Different…

Payroll Management - Tips To Make Payroll Processing Easier…


Ultimate Persuasion Strategies! - Secret Influence Tools & …

Introduction to Design of Experiments

Small Business Management Made Simple: Tools, Tips & Techni…

Design Control for Medical Devices and Combination Products

I-9 Audits: Strengthening Your Immigration Compliance Strat…


Employee Business Expense Reimbursement (2023 Updates)


Project Management for administrative professionals

Accounting For Non Accountants : Debit, Credits And Financi…

Establishing Appropriate Quality Metrics and Key Performanc…


Managing Toxic & Other Employees Who have Attitude Issues


Onboarding is NOT Orientation - How to Improve the New Empl…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…

The Importance Of Documentation For Supervisors And Managers