FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance (ONLINE EVENT) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance (Jan 21st - Jan 22nd, 2026)" training has been added to ResearchAndMarkets.com's offering.

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.

Learning Objectives:

• Understand FDA's recall authority and policy
• Learn how to manage recalls under FDA oversight
• Learn how to interact with FDA
• See how to develop health risk determinations
• Learn critical recall strategy components
• Manage possible FDA enforcement actions
• Many more....

Who Should Attend:

• Recall managers
• Quality assurance managers
• Regulatory affairs directors
• Risk and product liability managers
• Manufacturers' sales and marketing managers
• Own label distributors

Companies and departments:

• Manufacturers
• Own Label Distributors
• Importers
• Healthcare institutions
• Nursing homes
• Medical practice groups

Key Topics Covered:

Day 1 Agenda - Preparing for a Recall

Session 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

Session 2: Proactive Recall Readiness

• 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

Session 3: Risk-Based Planning & Early Decision Making

• 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

Day 2 Agenda - Executing & Closing a Recall

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

Session 5: Post-Recall Actions

• 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

Session 6: Case Studies and Interactive Wrap-Up

• 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

Speakers:

Kelly Thomas
Vice President
Stallergenes Greer

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

For more information about this training visit https://www.researchandmarkets.com/r/6o5wi6

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