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GlobalCompliancePanel, Online Training Webinar
2010-09-30
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: - 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 what 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
- Discuss most recent recalls not only for devices but pharmaceuticals and why the numbers are alarming
Who will benefit: 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 and departmental representatives and those who desire a better understanding or a "refresh" overview of the recall process from start to finish, including: - Regulatory Affairs
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Distributors/Authorized Representatives
- Legal Counsel
- Engineering/Technical Services/Operations
- Consultants
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.
Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.
Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
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Deadline for Abstracts:
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2010-09-28
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Registration:
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| | Live live online training only for one participant | | |
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E-mail:
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webinars@GlobalCompliancePanel.com
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