Dublin, Nov. 06, 2026 (GLOBE NEWSWIRE) -- "FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance (June 8th - June 9th, 2026)" has been added to ResearchAndMarkets.com's offering.
Research and Markets has made the recording of “FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance” available for on-demand purchase. The masterclass, led by course provider Kelly Thomas, was held live on June 8-9, 2026. It takes participants through the full recall lifecycle for drugs, devices and food: from building a recall plan before a problem arises, through execution, to closing a recall with the FDA.
Key Event Facts
- Course: FDA Recalls Masterclass: Proactive Preparation and Post-Recall Compliance
- Format: Recorded training, accessed online through a secure website
- Original live event: June 8-9, 2026 (EST)
- Course provider: Kelly Thomas
- Regulatory focus: 21 CFR Part 7, 21 CFR Part 806 and 21 CFR Part 810
Day 1: Preparing for a Recall
The first day sets out the essentials: recall definitions and classes, the legal framework under 21 CFR Part 7, the key agencies involved, and common causes of recalls for drugs, devices and food. Participants then learn how to build a recall plan and standard operating procedure (SOP), form a cross-functional recall team, track inventory and distribution, and run mock recall exercises. The day closes with risk-based planning: deciding when to recall, assessing health hazards using FDA criteria, preparing internal stakeholders, and creating communication templates.
Day 2: Executing and Closing a Recall
The second day covers execution: notifying the FDA, customers and the public, handling the media, and conducting effectiveness checks. Post-recall sessions address root cause investigation linked to corrective and preventive action (CAPA), recordkeeping, final status reports to the FDA, and preventive measures. The programme also covers FDA inspectional follow-up and enforcement, including administrative and legal remedies and mandatory recall actions under 21 CFR Parts 806 and 810. It ends with industry case studies, common pitfalls, a Q&A session and a takeaway checklist.
Why You Should Watch
- Understand recall classes and the 21 CFR Part 7 framework for voluntary recalls
- Build a recall plan, SOP and cross-functional team, tested through mock recalls
- Apply FDA health hazard criteria, including vulnerable subpopulations, to recall decisions
- Run effectiveness checks and manage FDA, customer, public and media communications
- Link root cause investigation to CAPA and prepare for FDA follow-up and enforcement
Course Provider
- Kelly Thomas
Regulatory, quality and compliance professionals who want to strengthen recall readiness and post-recall compliance can purchase the recording through Research and Markets. Access details are sent by email.
For more information about this training visit https://www.researchandmarkets.com/r/4bwdph
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