Recall Readiness: Dust Off Your SOPs, There’s a New Guidance in Town – Webinar Recording/Transcript
Are you recall-ready? Significant industrywide issues are triggering large, public recalls that have caught even the most sophisticated companies off guard.
But if you learn now what new things the FDA looks for in a smooth recall — evident in the agency’s recently released guidance on initiating voluntary recalls — you’ll have a better chance of conducting a compliant operation.
Richard Kingston, PharmD, president and cofounder 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 you can be recall-ready.
The two will share the procedures the agency finds critical to running an efficient recall by reviewing its recent final guidance. Mr. Kingston and Ms. McEnroe will show you ways you can recognize, understand and anticipate common pitfalls that lead to costly recall mistakes. And they’ll explain how to enhance internal communication between those responsible for recalls and those responsible for postmarket surveillance (PMS).
The pandemic created staffing challenges for everyone: personnel shortages, a glut of new hires and recently shuffled roles, and teams that have never worked together on a recall or pharmacovigilance issue. Now is your opportunity to turn these problems into recall solutions by training or retraining employees and creating connections among the various departments that must coordinate recall activities.
After attending this presentation, you will be able 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 exiting SOPs or recall plans to ensure that you are up to date with your 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 nonrecall 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
If you want 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 your recall and PMS staff and register for this webinar now.
Meet Your Presenter
Richard Kingston, PharmD, is co-founder and president of regulatory and scientific affairs, and senior clinical toxicologist at SafetyCall International, a multidisciplinary healthcare firm serving industry in the areas of postmarket medical surveillance, regulatory reporting support for adverse events and product safety. His professional and academic career spans more than 40 years and his expertise encompasses the areas of consumer product postmarket surveillance, poisoning epidemiology, clinical toxicology and pharmacology, injury prevention, poison control and product safety regulatory policy.
Diane McEnroe, a partner in Sidley Austin’s Food, Drug and Medical Device Regulatory practice group, has established long-standing relationships with domestic and international companies in the food, drug, medical device and personal care industries. She provides strategic counsel to clients on FDA regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph issues and postmarketing obligations, including adverse event reporting and food registry postings. Ms. McEnroe also has extensive experience advising on drug sampling programs, track-and-trace systems and state licensure issues.
Who Will Benefit
- Quality assurance/manufacturing professionals
- Corporate attorneys
- Risk management professionals
- Customer service personnel
- Regulatory affairs professionals
- Product safety/pharmacovigilance personnel
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June 23, 2022