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.
FDA Compliance And Laboratory Computer System Validation
The Anti-Kickback Statute: Enforcement and Recent Updates
Creating a Successful Job Rotation Program
Transforming Anger And Conflict Into Collaborative Problem …
Aligning Your HR Strategy with Your Business Strategy
How To Create Psychological Safety in your Organization
How to Give Corrective Feedback: The CARE Model - Eliminati…
Zero Acceptance Sampling to Reduce Inspection Costs
AI at Your Service: Enhancing Your Microsoft OfficeSkills w…
Identifying, Managing, and Retaining High Potential Employe…
Why EBITDA Doesn't Spell Cash Flow and What Does
Female to Female Hostility @Workplace: All you Need to Know
Human Factors Usability Studies Following ISO 62366 and FDA…
Developing and Implementing Quality Culture in the Organiza…
Dealing With Difficult People In Life & Work
How to Document Employee Discussions and Why it is Important
Project Management for Non-Project Managers - How to commun…
FDA Recommendations for Artificial Intelligence/Machine Lea…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Enhancing Pivot Tables with Images: Visualize Your Data Lik…
How to Deal with Employees Who Love to Argue and Debate Eve…
How to Write Contracts for Procurement Professionals
Project Management for administrative professionals
Sunshine Act Reporting - Clarification for Clinical Research
Reprogramming your mind for Corporate Excellence: 4 Steps t…
Terminating Toxicity: Strategies For Leaders To Confidently…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Onboarding Best Practices for 2025: Proven Strategies to Po…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Uplifting the Credibility of HR: How to Build the Credibili…
How to Write Effective Audit Observations: The Principles f…
Strategic Interviewing & Selection: Getting the Right Talen…
Bridging Generational Divides in the Workplace
Onboarding Best Practices for Millennial and All Employees
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Emotional Intelligence: Mastering the Emotions of Great Lea…
FDA Audit Best Practices - Do's and Don'ts
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Pay Transparency in Action: Strategies for Building Trust a…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …