Welcome to the home page for the Jacksonville - Northeast Florida Section of the American Society for Quality. We hope you will find our Web site interesting and useful. Here, you may contact the Section Officers and become better acquainted with Section activities.
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The Section 1506 is pleased to announce our August meeting.
Date: Wednesday, August 28, 2019
Presentation: “5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process”.
Presented by: Wayner Williams, CQA
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
This talk 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.
Wayner Williams, CQA
Wayner Williams is a regulatory and quality professional with over 25 years of experience delivering compliant, audit ready quality system solutions that support new product introductions, regulatory submissions and global quality system requirements for the medical device and pharmaceutical 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.
2019 JEFFERY IRVIN LACKEY SCHOLARSHIP AWARD
ASQ Section 1506 is proud to announce the 2019 scholarship application period has begun. This year the scholarship amount will be at least $1,000. The Deadline for the SCholarship application is June 10, 2018.Clik the link below for more information
GET INVOLVED - BE A MEMBER LEADER
ASQ 1506 is searching for individuals interested in serving on the ASQ Section 1506 2019 Board. If you are interested in serving, please contact the section’s Nominating Chair, Henry Burkard at firstname.lastname@example.org
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