Setction Meeting: New Regulations for Managing Risk and Clinical Issues Aimed at the design of Medical Device

Many of us work in a regulated environment.  Very recently the medical devices have come under the scrutiny of the Health Authorities. Please attend this meeting to find out what happened, what is being done about it and how pertinent regulation have been changed. Many of you probably don’t know what a medical device is.  Believe or not a felt tipped pen would be considered a medical device if a surgeon uses it to draw on a patient to indicate an incision point.  Come to this meeting and be educated as to new ideas and trends .

Presented by:  Nancy J. Sperling, MS QA/RA, Green Belt and CQA

Nancy is a Quality Assurance and Regulatory Compliance Professional.  She has over 20 years of work experience which involved with pharmaceutical, biologics, medical devices, and consumer health products. Education includes and MS in Toxicology from St. John’s University and an MS in Quality Assurance and Regulatory Affairs from Temple University. 

Nancy believes in giving back to the community and volunteers for the following organizations: Fair Lawn Green Team, Environmental Commission, Gardening committee, mentored and instructed Middle school and High school students as per STEM as a volunteer of Students 2 Science and is an ACS volunteer career counselor.

Nancy has the following ASQ certifications: Certified Six Sigma Green Belt, and Certified Quality Auditor.

Date & Time: Tuesday, October 8, 2019 6:30pm-8:30pm

Location: Spanish Tavern, 103 McWhorter Street – Newark, NJ 07105

Registration: (Dinner will be provided)

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