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Recall Readiness, Dust Off Your SOPs, There’s a New Guidance in Town Webinar on June 15, 2022

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FALLS CHURCH, Va. (PRWEB)

Recall Readiness

Dust Off Your SOPs, There’s a New Guidance in Town

An FDAnews Webinar

Wednesday, June 15, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/recall-readiness

Recalls never come at a good time. But being prepared can help with running an efficient and smooth operation once the need for a recall hits.

Drug and device-makers don’t want to start dusting off the old recall procedures and begin to retrain those responsible for implementing them at the moment they should be jumping into recall mode. The FDA wants them to avoid this, too, which is why it’s important to understand its new guidance on initiating voluntary recalls.

Richard Kingston, PharmD, co-founder and president of regulatory and scientific affairs and senior clinical toxicologist at SafetyCall International, and Diane McEnroe, a partner in Sidley Austin’s Food, Drug, and Medical Device Regulatory practice group, will explain exactly what the FDA wants and how to get recall-ready. Specifically, they will empower attendees to:


  • Understand the key components of the guidance Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, including identifying and training appropriate personnel and developing a recall action plan

  • Determine potential reporting obligations associated with affected products, recordkeeping, and other legal obligations

  • Evaluate existing SOPs or recall plans to ensure that drug and device manufacturers are up to date with their recall approach, including enhanced training

  • Identify the types of product issues that can lead to a recall, including which ones may constitute low-risk issues that can be managed with non recall mitigation measures, such as market withdrawal or other corrective actions

  • Implement a PMS system to quickly identify and act on safety signals, including identifying and evaluating adverse event reports and other safety signals

  • Conduct a health hazard evaluation (HHE), including using qualified individuals to conduct the evaluation and characterizing the risk and the need for potential mitigation steps to help ensure patient safety and avoid pitfalls that can lead to costly mistakes

Manufacturers need a team that understands what the FDA expects in an efficient recall assessment/implementation, a team that can run a smooth operation that ensures patient safety and saves money, gather recalls and PMS staff, and get them on this webinar.

Webinar Details

Recall Readiness

Dust Off Your SOPs, There’s a New Guidance in Town

An FDAnews Webinar

Wednesday, June 15, 2022, 1:30 p.m.–3:00 p.m. EDT

https://wcg.swoogo.com/recall-readiness

Tuition:

$287

Easy Ways to Order:

Online: https://wcg.swoogo.com/recall-readiness

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations.

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