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Production and Process Control: Building a Robust System for Medical Device Companies
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Instructor Profile:
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Description:
Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce products. P&PC is critical to producing safe and effective products for your customers. It is a broad area covering environmental, personnel, contamination, building, equipment, inspection, materials, and more. Because of its criticality, P&PC is one of areas most closely inspected by the FDA. This webinar will help you understand what is necessary for P&PC and how to integrate it seamlessly with the rest of your Quality Management System.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Objectives of the Presentation:
This webinar will cover:Overview of the regulationsFDA expectationsLessons learned and common mistakesBest practicesPreparing for an FDA inspection
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Areas Covered:
This webinar will cover:Establishing P&PC Change control Environmental control Personnel requirements Contamination control Buildings Equipment Manufacturing material Automated processes Inspection, measuring, and test equipment Process validation Linkages to the total product life cycle and risk management Process improvement Installation procedures including inspection and testing Important linkages to other QMS requirements.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Who can Benefit:• QMS Auditors• Quality Engineers• Manufacturing Engineers• Manufacturing Supervisors• Manufacturing/ Production /Operations Supervisors, Managers, and Directors• Plant Managers• Quality Managers• Employees new to Medical Device Companies.
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Production and Process Control
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
