Product Details
Are you recall ready? Recalls are increasing and the FDA issued new recall guidance. If you’re at all unsure, you need Recall Readiness: Preparing to Meet FDA Requirements.
This management report is the key to understanding what the FDA expects from your recall assessment and implementation, providing critical advice on how to train and deploy and/or retrain a team that can run recall-related activities smoothly and efficiently in compliance with the agency’s recently published guidance on the topic.
At the same time, the pandemic has left many companies short-staffed, working with new hires, employees moving into new roles and teams who have little experience with pharmacovigilance and recall management. And right now, significant issues are triggering an increasing number of public recalls, catching even large, regulatorily savvy companies off guard.
Recall Readiness is the solution to it all.
From practical instruction on systems review and how to improve and enhance existing internal processes to refresh training for recall-involved staff, this report gives you everything you need to know and do to meet the FDA’s new recall guidance. It will ensure an efficient evaluation and update of your recall procedures so if you must run one, you can do it quickly and compliantly, despite today’s staffing challenges.
Management Report Takeaways:
- The key components of the final FDA guidance, along with identifying and training personnel and developing an effective recall action plan
- How to best evaluate existing SOPs or recall plans to ensure that your company’s recall approach meets expectations described in the guidance, as well as enhanced training
- How to determine potential reporting, record-keeping and other legal obligations associated with products affected by a recall
- What types of product issues could potentially lead to a recall and which constitute low-risk issues that can be managed with other approaches, such as market withdrawal or other corrective actions
- The qualities of an effective postmarket surveillance system that can quickly identify and respond to safety signals, such as adverse event reports
- How to use qualified individuals to conduct an effective health hazard evaluation to characterize the risk and need for mitigation of safety signals
Recalls happen and they’re increasing: Be sure you and your team are ready for a compliant recall assessment and implementation with Recall Readiness: Preparing to Meet FDA Requirements.
About the Contributors
Rick Kingston, PharmD, is cofounder, president, 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 is a partner in the Food, Drug and Medical Device Regulatory Practice Group at Sidley Austin, where she provides clients strategic counsel 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
Add to Cart
Contributors:
Rick Kingston and Diane McEnroe
ISBN-13:
978-1-60430-199-1
Publication date:
Aug. 2022
Page count:
59
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