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Summary:“Current Good Manufacturing Practice for Medical Devices Including IVDs” is the topic of a RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on November 27.Dr. David Lim, a certified RAC and Certified Quality Auditor (CQA), will be the speaker at thiswebinar, which earns up to 1.00 RAC credits towards a participant's RAC recertification upon full completion. ----------------------------------------------------------------------------------------------------------------- Description: This webinar talks about the current Good Manufacturing Practice (cGMP) for medical devices, including in vitro diagnostic medical devices. All medical devices are subject to Good Manufacturing Practice (GMP). This session will familiarize participants with the Current Good Manufacturing Practice (cGMP) present in the medical devices industry. This includes in-vitro medical devices. This session will also proffer guidance on the cGMP requirements as stated in the Quality System Regulations (QSRs), which ensure that medical devices are safe and effective for their intended use. Why is an understanding of QSRs important? Because, showing deep understanding of QSRs helps speed up the approval process. The benefits of getting compliance of medical devices are there for everyone to see: a significantly enhanced saving of time, effort and resources. This webinar is a useful tool to helping participants gain a better understanding of how to bring these about. A result of participation in this webinar is that participants will be better equipped to handle situations relating to which approach to take when implementing their cGMP’s, and how to use their judgment and discretion for better results. This session will cover the following areas: o Overview and review of the US QSRs for medical devices o Flexibility of the QSRs o Definitions o Quality System Requirements o Management responsibility o Audits o Personnel o Design Control o Validation, design transfer, and design changes o Design History File (DHF) and Device Master Record (DMR) o Quality System procedures o Purchasing controls o Inspection, measuring and test equipment o Process Validation o Corrective and Preventive Action (CAPA) o Complaint Files o Servicing o Quality requirements for premarket approval (PMA) application o Enforcement actions: case studies o Lessons learned ----------------------------------------------------------------------------------------------------------------- When:November 27, 10:00 AM PDT 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom:Dr. David Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal, Science. Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. ----------------------------------------------------------------------------------------------------------------- For whom: The webinar will benefit o CEOs o VPs o Compliance officers o Attorneys o Clinical affairs o Regulatory affairs o Quality assurance o R&D o CROs o Consultants o Contractors/subcontractors ---------------------------------------------------------------------------------------------------------------- Duration: 60 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact webinars@globalcompliancepanel.com Phone: 800-447-9407 AMAZINES.COM
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online Training, Good Manufacturing Practice, Medical Devices, IVDs, Quality System regulations, QS, cGMP, Design history file, DHF,
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