How to Manage a Medical Device Recall Efficiently and Effectively
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This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.
Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company.
A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.
Areas Covered in the Session:
Who will benefit
- Create and use a recall operational procedure and what should it contain
- Understand what are effectiveness checks
- What happens in a medical device recall
- Learn why a recall is either a correction or a removal depending on where the action takes place.
- Understand why is required for the recall strategy as expected by FDA
- Medical device recall authority and guidance
- Depth of recall and using a viable, sustainable and effective strategy
- Understand why the documentation and paper trail are so critical and termination of a recall
This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. The employees who will benefit include:
- All levels of Management for all departments and those who desire a better understanding
- QA/QC/Compliance/Regulatory Affairs
- Marketing & Sales
- Engineering/Technical Services
- Operations and Manufacturing
David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry.
He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM's/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations.
Mr. Dills most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.
He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products.
David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.
He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk.
He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.