Join our 2-day online FDA Recalls Masterclass to learn proactive strategies for recall preparation and post-recall compliance.
This course will teach how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it." FDA's recall authority and program launches you into a project of crisis management.
Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.
You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.
This course will teach how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that, "You don't get it." FDA's recall authority and program launches you into a project of crisis management.
Your compliance competency becomes a regulatory issue for the FDA if your recall is deemed ineffective. The seminar will cover critical performance targets for conducting an effective recall. You will learn how missteps in the recall process become an expensive problem in terms of money and a sloppy corporate image.
You will take away practical knowledge on how to work with FDA staff during a recall, and how you can prepare for inspectional follow up or a regulatory action, and in some cases a legal action. You will learn that your approach to recalls plays a major role in mitigating direct and indirect damage to your firm's business. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the negative impact of a recall with the use of proper planning.
Course Content
Day 1
FDA’s Regulatory Authority
- Recall Regulations
- Voluntary recall: 21 Code of Federal Regulations (C.F.R.) Part 7
- Mandatory recall actions
- 21 C.F.R. Part 810
- 21 C.F.R. Part 806
Recall Classification
- Violation of the law
- Risk to Health
- Precedents
- Exemptions
- Stock Recovery
- Product Withdrawal
- Product Improvement
Recalls and Risk to Health
- Risk to health categories
- Death
- Serious injury / serious illness
- Non-reversible / reversible
- May cause, if it were to recur
- Remote possibility
- Health Hazard Evaluation for Recall Classification
- FDA’s internal evaluation
- Vulnerable subpopulations
- Scoring
- Participants
- Industry HHE equivalent
- FDA’s recall database
Day 2
FDA’s Recall Procedures
- Understanding FDA’s program and implementation
- FDA’s agency-wide recall procedures
- The FDA’s investigator’s job
- Preparing a recall strategy
- Preparing for FDA oversight
- Recall notification to FDA’s District Office
- Recall notification to the public
- Root cause identification
- Correction and Prevent Action (CAPA)
FDA inspectional Follow-up
Enforcement: FDA Administrative and Legal Remedies
End
Agenda
Day 1 Agenda - Preparing for a RecallSession 1: FDA Recalls - The Essentials
- Understanding FDA recalls: definitions, types (Class I, II, III)
- Legal and regulatory framework: 21 CFR Part 7
- Key agencies and stakeholders involved
- Common causes for recalls in drugs, devices, and food
- Building a compliant recall plan and SOP
- Setting up a cross-functional recall team
- Inventory control, distribution tracking, and documentation essentials
- Mock recall exercises: importance and implementation
- When to recall: risk analysis and decision criteria
- Assessing health hazards and classification impact
- Preparing internal stakeholders for emergency response
- Creating effective communication templates in advance
Session 4: Executing the Recall
- Initiating a recall: step-by-step execution
- Notification procedures: FDA reporting, customer and public notification
- Managing media and public communications
- Effectiveness checks: ensuring compliance and outreach
- Root cause investigation: linking with CAPA
- Documentation and recordkeeping during and after a recall
- Final status reports to the FDA
- Preventive measures and strengthening systems
- Industry recall case studies: good and bad practices
- Discussion: common pitfalls and best practices
- Live Q&A with recall compliance expert
- Takeaway checklist and regulatory resources
Course Provider
Kelly Thomas,
