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Summary:GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “Process Validation Principles and Protocols for Medical Devices”, on November 15. Jeff Kasoff, RAC, Director of Regulatory Affairs at Life-Tech, Inc., will be the speaker of this 60-minute webinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Description: One of the hallmarks of a scientific process is that it should be consistently and repeatedly demonstrable and predictable.Process lies at the heart of a high-specialty product such as a medical device, because this is what helps the device meet expected criteria. This is why a medical device has to meet very stringent and robust process validation and verification requirements when being manufactured. That process validation is a core part of both automated and manual devices is an indication of the importance process validation and verification has to medical devices. It has to be carried out in such a way that it consistently meets set domestic and international standards. This webinar will familiarize participants with the ins and outs of process validation and verification. Participants of this session will gain an in-depth understanding of the topic. These are the areas this webinar will address: o What is Validation? o When should it be used? o How does it differ from verification? o Validation vs. Verification: Which One? o Protocol preparation o Different types of validation o IQ, OQ, and PQ ----------------------------------------------------------------------------------------------------------------- When:November 15, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: 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. In this position, Jeff holds the critical portfolio of being responsible for oversight of corporate compliance with domestic and international regulations and preparation of submissions, and is the primary liaison point with regulatory agencies and notified bodies. Performing such challenging tasks day in and day out has given Jeff deep knowledge of regulatory affairs, which he has imparted in the dozens of webinars he has presented 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. Delivering on challenges has thus never been new to Jeff. Jeff received his Regulatory Affairs Certification in 1996. ----------------------------------------------------------------------------------------------------------------- For whom: o Validation Specialists/Managers o Process Engineers o Manufacturing Engineers o Quality Engineers o Product/Process Development personnel o Research and Development personnel o Quality/Regulatory Personnel ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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