Design Controls are a set of quality practices and procedures which govern medical device design.
They are promulgated in 21 CFR 820.30 of the Quality System Regulation and are intended to ensure that user needs and intended uses are met and that finished devices are safe and effective for their intended use.
An effective Design Control system connects key Quality Management Subsystems and impacts not only pre-market design and development, but also impacts post market device management.
This webinar will begin with a brief overview of Design Controls followed by the 5 key QMS subsystems that when connected to the Design Control process create an effective audit proof Design Control system. You will also discover the roll that these key connections play in post market vigilance activities and the one “must have” tool to aid in the process.
SPECIFICALLY This Webinar will Cover:
- Overview of Medical Device Design Controls
- 5 Key QMS Subsystems that must connect to the Design Control Process
- The role these key connections play in post market vigilance activities
- The one “must have” tool to aid in making these critical connections
Who should attend?
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Medical Device Industry Executives
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Regulatory Affairs Professionals and Management
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Quality Professionals and Management
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Clinical Affairs Professionals and Management
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R&D Engineers and Management
ABOUT THE PRESENTER:
Wayner Williams is a regulatory and quality professional with Medpoint LLC. Wayner has over 25 years of experience delivering compliant, audit ready quality system documents and solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device industry. She holds a Bachelor of Science degree in Chemical Engineering, Masters in Materials Science & Engineering and Masters in Pharmacy.
Wayner brings real industry experience to the medical device industry. She has worked in multiple areas including new product development, project management, developing and implementing quality systems and implementing product lifecycle management systems which interconnect and render useable all of the information required to demonstrate quality system compliance to regulatory bodies. She is a Certified Quality Auditor and has served as SME in numerable regulatory audits and inspections.
Extensive knowledge of quality system deliverables, including design control, risk management and pre-market regulatory submissions have afforded her the opportunity to assist many organizations in implementing and sustaining real time audit ready and compliant quality systems. She is passionate about regulatory affairs and quality and currently serves as section chair for the Northeast Florida section of the American Society for Quality (ASQ).
