Dublin, July 25, 2023 (GLOBE NEWSWIRE) -- The "FDA Recalls - Before You Start, and After You Finish - Best Practices and Common Pitfalls Training Course - 2 Day" training has been added to ResearchAndMarkets.com's offering.
This interactive training aims to equip participants with a roadmap for conducting recalls, making informed recall management decisions, and developing effective recall procedures aligned with FDA (Food and Drug Administration) guidelines.
Learning Objectives:
The course covers various critical aspects of recalls, including understanding FDA's recall authority and policy, managing recalls under FDA oversight, interacting with the FDA during a recall, developing health risk determinations, and key components of recall strategy. Participants will also learn how to manage possible FDA enforcement actions and gain practical knowledge on working with FDA staff during the recall process.
Who Should Attend:
This training is relevant for professionals in roles such as recall managers, quality assurance managers, regulatory affairs directors, risk and product liability managers, manufacturers' sales and marketing managers, and own-label distributors. It is valuable for companies and departments involved in manufacturing, own-label distribution, importation, healthcare institutions, nursing homes, and medical practice groups.
Key Topics Covered:
Day 1:
- Understanding FDA's Regulatory Authority and Recall Regulations, including voluntary and mandatory recall actions.
- Recall Classification and different categories based on violation of the law, risk to health, exemptions, stock recovery, product withdrawal, and product improvement.
- Recalls and Risk to Health, covering health hazard evaluation, FDA's internal evaluation, and factors influencing recall classification.
Day 2:
- FDA's Recall Procedures, including agency-wide recall procedures, the role of FDA investigators, preparing a recall strategy, and handling recall notifications to FDA's District Office and the public.
- Root cause identification and the importance of Correction and Prevent Action (CAPA) in recall management.
- FDA inspectional follow-up and enforcement, involving FDA administrative and legal remedies.
Speaker:
The training will be conducted by Kelly Thomas, Vice President at Stallergenes Greer, with over two decades of hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Ms. Thomas's expertise covers all Quality Systems and areas of validation, including process/product validation, facilities validation, CSV (Computer System Validation) and 21 CFR Part 11 compliance, test method validation, equipment/automated processes, and cleaning validation. With a strategic and risk-based approach, she has successfully managed complex projects within the pharmaceutical and medical device industries.
In conclusion, the "FDA Recalls - Before You Start, and After You Finish - Best Practices and Common Pitfalls Training Course - 2 Day" offers a comprehensive and practical guide to managing recalls effectively in compliance with FDA regulations. Participants will gain valuable insights to prevent costly missteps and safeguard their firm's business and reputation during recall situations.
For more information about this training visit https://www.researchandmarkets.com/r/pakj0y
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