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GlobalCompliancePanel, Online Training
2011-01-19
Overview: In this presentation, we will review recent medical device manufacturers Warning Letters to determine the inadequacies of responses by manufacturers. After finding the weaknesses in the responses, we will identify those characteristics of an adequate response by manufacturers to avoid a Warning Letter and additional enforcement actions by FDA. All medical device companies preparing for FDA inspections should review the information in this presentation and prepare a plan for response to an FDA-483 before the FDA arrives. There will be insufficient time to react during an inspection and after an FDA investigator leaves a FDA Form 483 to develop a response without prior preparation.
Why you should attend: Some of the Warning Letters issued by FDA are issued because the manufacturer has failed to respond to inspection observations (FDA-483) in a timely manner or without sufficient information or with weak responses. The number of Warning Letters issued in 2010 is much greater than those issued in earlier years. Medical device manufacturers can reduce the possibilities of receiving Warning Letters with timely adequate responses.
Areas Covered In the Seminar: - Review actual medical device Warning Letters
- Identify common weaknesses that lead to Warning Letters
- Lack of timely response
- Lack of sufficient information
- Appearance that manufacturer is not serious about responsibilities
- Prepare for inspection response
- Develop FDA 483 Response Plan
- Assign responsibilities
Who will benefit: - Regulatory Management
- Quality Management
- Quality Engineers
- Internal Auditors
- Company senior management
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
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Deadline for Abstracts:
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2011-01-19
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Registration:
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Wednesday, January 19, 2011 10:00 AM PST | 01:00 PM EST | | Live live online training only for one participant | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | |
| | Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) | |
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E-mail:
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webinars@globalcompliancepanel.com
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