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
Managing Difficult Employee Conversations
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Dealing With Difficult People In Life & Work
Predictive Accounting: Driver-Based Budgeting And Rolling F…
Pay Equity Changes for 2024! What Employers Need to Know to…
Leader Branding: How to Communicate with Confidence to Attr…
Project Management for Non-Project Managers - How to commun…
Design Verification, Validation and Testing for Medical Dev…
Data Integrity and Privacy: Compliance with 21 CFR Part 11,…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
Why EBITDA Doesn't Spell Cash Flow and What Does
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Employee or Independent Contractor – U.S DOL Announces 2024…
How to Survive an Emotionally Toxic Workplace
Best Practices in Complaint Management for Regulatory Compl…
Human Factors Usability Studies Following ISO 62366 and FDA…
Ensuring Safe and Effective Pharmaceutical Products: A Comp…
Gossip-Free: Leadership Techniques to Quell Office Chatter
Updated Metro 2®, e-OSCAR and the New Tougher FCRA/CFPB Com…
Embracing Diversity and Inclusion in Talent Acquisition
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Understanding and Analyzing Financial Statements
Divorce, Adoption and Other Special Tax Topics
Design History File (DHF), the Device Master Record (DMR) a…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Setting up Quality System for FDA Regulated Products: Tips …
Is Your Culture Working For or Against Your Success? If You…
Marketing to Medicare or Medicaid Beneficiaries - What You …
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
Sunshine Act Reporting - Clarification for Clinical Research
Documenting Misconduct that Will Stand Up in Court
Stress, Change And Team Resilience Through Humor: An Intera…
FDA Regulation of Artificial Intelligence/ Machine Learning
Managing Toxic & Other Employees Who have Attitude Issues
Excel - Lists and Tables - A Beginner's Guide to Managing L…
Pharma 4.0: Next Generation Technology Approach to GxP Prod…
Patient Gifts, Discounts and Freebies: What You Can and Can…
Managing Complex Projects - Project Management
All About Civility - Eliminating a Culture of Gossip Rumors…
From Challenges to Compliance: Understanding Dietary Supple…
Improving Employee Engagement & Retention Through Stay Inte…
How To Conduct An Internal Harassment And Bullying Investig…