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GlobalCompliancePanel, Online Training
2011-01-13
Overview: To satisfy QSR and ISO 13485 requirements, medical device companies must respond to field reports swiftly and compliantly. There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. FDA and ISO requirements overlap to a great extent, but not completely. This webinar sets forth the requirements for recalls, removals, and market corrections, and provides recommended practices.
Why should you attend: There are certain circumstances in which a report from the field requires the device manufacturer to take steps regarding product in the field. It is critical that the company take the required steps in the required timeframes. If not, FDA's sanctions could be so onerous as to result in the company's inability to ship product. Areas Covered in the Session: - Regulatory definitions of recalls, removals, and market corrections
- Instances which require recalls, removals, or market corrections
- What to do during recalls, removals, and market corrections
- Recordkeeping requirements for recalls, removals, and market corrections
- ISO 13485-specific requirements
- CMD-specific requirements (Canadian device regulations)
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since personnel training is a regulatory requirement in the Medical Device field. The employees who will benefit include: - Regulatory Management
- Quality Assurance Professionals
- Consultants
- Sales/Marketing Management
- Senior and mid-level Management
- Quality System Auditors
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff has presented dozens of webinars in many areas dealing with regulatory compliance. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
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Deadline for Abstracts:
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2011-01-13
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Registration:
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Thursday, January 13, 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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