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.
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.
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.
Meredith Crabtree
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.
AI for Project Managers: Smarter Planning Reporting and Com…
Mastering Performance Management: Strategies for Continuous…
ChatGPT for Innovative Business Advisory Services for Accou…
Female to Female Hostility @Workplace: All you Need to Know
Latest Trends in Human Error Reduction in GMP Manufacturing
Bootcamp for New Managers and Supervisors: Develop These Es…
Analytical Method Validation Under Good Laboratory Practice…
2-Hour Virtual Seminar on The Complexity and Interplay Amon…
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Data Integrity and Privacy - Compliance with 21 CFR Part 11…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
Payroll Record Keeping: How to Thin Out File Cabinets and Q…
Medical Device Cybersecurity Following FDA’s 2026 Premarket…
Construction Lending And Real Credit Administration: Evalua…
HIPAA Compliance in 2026 — Practical Strategies for Breach …
Moving From an Operational Manager to a Strategic Leader
Launch Your Career: The Ultimate Guide for Emerging Profess…
Dealing With Difficult People: At Work & In Life
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Discover how Emotional Intelligence turns AI from a technic…
The 6 Most Common Problems in FDA Software Validation and V…
High-Impact Performance Management: Tools, Tactics & Coachi…
The 60 Minutes Introduction to DAX
Empowering Conflict Resolution: Letting Go to Gain Control
AI Across the Business: Practical Use Cases for Founders an…
Faster, Better Talent Acquisition: Leveraging AI & ChatGPT …
The Anti-Kickback Statute: Enforcement and Recent Updates
Goal Mastery: From Resolutions to Results in 2026
Your AI Advantage: How HR Professionals Can Use Claude to S…
Human Error Reduction Techniques for Floor Supervisors
Validation of FDA-Regulated Medical Device and SaMD Product…
Human Factors Usability Studies Following ISO 62366 and FDA…