Quality System Implementation for Early Stage Med Tech Companies
Sponsored by Drexel University Center for Graduate Studies
Julie Jenks, M.S., Quality Assurance Consultant
NorCal Quality Consulting
The establishment of a Quality System is a requirement of all U.S. and International regulatory agencies for organizations that design and/or develop medical devices. An effective Quality System will save a Med Tech company time and money by helping to ensure that its final product meets customer and regulatory requirements (in other words that it does what it is expected to do).
This course will detail the components of a Quality System and discuss the reality of implementing of an effective Quality System in an early stage Med Tech company.
Points to be Covered:
- The components of an effective Quality System, including Design Control, Risk Management, Auditing, Purchasing Controls, and Validation
- U.S. FDA (21 CFR §820) versus ISO (13485:2003) Quality System requirements.
- Implementation of a Quality System in an Early Stage Med Tech Company
- Quality and Clinical Trials
Julie Jenks, M.S. has over ten years of experience in the biotechnology industry. She has worked in several positions contributing to the development of in vitro diagnostics and medical devices, most recently at Roche Molecular Systems in Pleasanton, CA. For the past two years she has been providing Quality Assurance consulting services for Medical Device companies in Northern California as the Sole Proprietor and lead Quality Assurance consultant for NorCal Quality Consulting.
Wednesday, March 28, 2012
8:45 am - 11:30 am
Registration, breakfast and networking from 8:45-9:00 a.m.
Drexel University, One Capitol Mall, Suite 260, Sacramento, CA 95814
General Admission: $40; SARTA Members: $25
Price includes free parking for 4 hours at the One Capitol Mall Valet Garage on 2nd Street (valued at $8) and a continental breakfast.
If you are a SARTA member, please email firstname.lastname@example.org for member discount code.