Medical Device Corrections and Removals, Recalls and Closures – Webinar Recording/Transcript
Medical Device Corrections and Removals, Recalls and Closures: Best Practices for Call Center Operations and Notice
Are you prepared to tackle recall operations? Often, what separates robust devicemakers that stay in compliance from those that fail is their grasp of corrections and removals, recalls and closures.
The business-savvy understand the complex and interconnected processes and multiple players involved in recall operations in advance. They hone their call center operations and notices protocols before they need to deploy them.
Further complicating the situation is the FDA’s improved infrastructure and relatively recent issuance of guidance documents for use in circumstances where field actions are not triggered by a specific regulatory violation, but instead are based on the manufacturer’s judgment.
With folklore and rumors dominating the talk about recalls operations, you need a trusted source for the facts. Tom Brockhaus, senior vice president, business development and client services, Recall Results, and Seth Mailhot, a partner and lead, FDA regulatory practice group, Husch Blackwell, will explain these often-misunderstood processes from beginning to end: medical device reporting requirements, recall classifications, medical device tracking, training topics of call center agents, preparing informative telephony on-hold messages, preparing mail files to increase delivery rates and methods of conducting effectiveness checks.
This presentation will enable you to identify, navigate and use the exceptions, required records and various reporting methods and their issues to help you ensure any corrections, removals, recalls or closures have the minimum impact on your business.
- The benefits and methods of data cleansing mail files, such as Coding Accuracy Support System (CASS) and National Change of Address (NCOA) to avoid wasting resources and to increase delivery rates of important recall communications
- The differences between First Class Mail and Certified Mail and considerations on what method to use
- Understanding the different approaches to conducting effectiveness checks, including use of automated telephony feedback systems
- The importance of training call center agents on topics such as recall sensitivity, handling of escalations and identification of incidents
Ensure compliance of recall with an understanding of recall operations best practices. Join us by registering today.
Meet Your Presenters:
Tom Brockhaus is senior vice president of business development and client services at Recall Results. He works with companies large and small as a strategic partner for product recall planning, management and outsourced services. Mr. Brockhaus’ experience and expertise extends across the product recall landscape, having performed recall programs for many of America’s leading corporations, working closely and cooperatively with key government regulatory agencies.
Seth Mailhot is a partner and lead of the FDA regulatory practice group in Husch Blackwell’s Washington, D.C. office. His 14 years working in the FDA has provided him a unique perspective when counseling clients on a broad range of matters involving the agency. Mr. Mailhot’s practice includes representation of the medical device and pharmaceutical industries, and covers both premarket and post-market issues. His practice is focused on development of premarket submission strategies and FDA enforcement of good manufacturing practices, both domestically and abroad.
Who Will Benefit:
Personnel with responsibilities in:
- Product Safety
- Reverse Logistics