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

Contractor vs Employee: How to Tell the Difference and What…

Imposter Syndrome: How to Define, Understand & Shift Your E…

FDA current recommendations related to timely initiation of…


Impact Assessments For Supplier Change Notices

Implicit Bias: Becoming Aware of Your Inner Storyteller

Complying with the NEW I-9 and E-Verify Regulations - The I…

The Federal Anti-Kickback Statute & Stark Law: What Physici…

Building an Effective Injury Management Process

Fatal Errors Employers Make When Updating Employee Handbook…

Understanding the Changes Coming to NCCI's Experience Mod i…

From Awareness to Action: Going Beyond the Law in Preventin…

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


From Awareness to Action: Going Beyond the Law in Preventin…


FDA Compliance and Clinical Trial Computer System Validation

5 Proven Ways To Engage & Retain Your Team Even During The …


Customer Relationship Management: Strategic Methods to Mana…

Navigating New Paths: Unveiling Your Unique Abilities for a…

Form 1099 Update 2023: Latest Forms, Rules and Reporting Re…

Strategic Interviewing & Selection: Getting the Right Talen…



Project Management for Non-Project Managers - How to Effect…

Implementing a Robust Change Control Program - Key Elements…

Amazing (!) AI Tools For Building Your Business



Excel - Unleashing the Full Potential of New Functions (Exc…

How to Conduct Annual Product Reviews to Achieve GMP Compli…



What Business Leaders Need to Know About Cybersecurity Prep…

Responding to EEOC Discrimination Charges-What's Your Busin…

Harassment, Bullying, Gossip, Confrontational and Disruptiv…