Why Should You Attend:
When considering the requirements for process monitoring and measurement, the first thought is usually in regard to production processes. However, ISO 13485 and ISO 9001 require companies to monitor and measure all quality system processes. Too often, this is either ignored, considered to be addressed by internal audit, or focused primarily on cycle-time reduction; none of which actually address the intent of the requirements. This webinar will help attendees to better understand those intents, how to meet them to realize business value rather than just compliance, and to avoid common mistakes that can result in reduced business valueless clinical trials, nor bulk-solution processes. It applies to unitized products such as pills, drug-filled syringes, medical devices, and components.
Areas Covered in the Webinar:
Who Will Benefit:
Steve Gompertz is a leader in Quality Systems management with over 25 years' experience in the life-science industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical, Boston Scientific, Medtronic, Vital Images, and Control Data. He is currently President of Quality Management Systems Potential LLC, a consulting firm focusing on medical device quality. Steve also helped develop and is an Adjunct Instructor in St. Cloud State University's Master of Science in Medical Technology Quality program. He holds a B.S. in Mechanical Engineering from Lehigh University, and certifications in quality management, biomedical auditing, regulatory affairs, project management, and configuration management.
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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