Monthly Archives: April 2016

May General Meeting 🗓 🗺

Meeting date – Wednesday, May 11th 2016
Time: 6.00pm

Venue – Pescatore Palace
3400 N River Rd Franklin Park IL. 60631

Cost – $30 (members and non-members)

Menu – Focaccio Bruschitta
Mostaccolay/marianna sauce
salad/dressing
Chicken breast vessovio
Beef medallion
Roast potatoes
Green beans
Ice cream
Coffee/soda

Topic- FDA Inspections and “GO” 101
Speaker – Karen Masley-Joseph
https://www.linkedin.com/in/karen-masley-joseph-6ab6b03

Presentation:
Synopsis: This presentation will provide an overview of FDA’s Office of Global Regulatory Operations and Policy (GO) and FDA’s interaction with industry through inspections. It will describe how GO operations impact you as a consumer and provide some helpful references for when and how FDA interacts with the industries it regulates.
Presenter: Karen Masley-Joseph is a Case Review Expert in the Office of Regulatory Affairs (ORA) at the Food and Drug Administration (FDA). In this role, Karen leads enterprise-wide improvements of FDA compliance processes and provides consults to the Department of Justice on enforcement actions of medical devices, pharmaceuticals and dietary supplements. In her 14 years at FDA, Karen has held many positions including the Director of the ORA Quality Management System Staff (QMSS), Regional Quality System Manager, Medical Device Investigator, and Compliance Officer. As QMSS Director, Karen managed successful audits with international regulatory partners, led the development of the first QMSS outcomes based strategic plan, and successfully led a team to achieve ISO 17025 laboratory accreditation within 6 months. In other roles, Karen contributed to joint FDA/industry initiatives to advance the quality of medical devices and has conducted numerous FDA inspections of domestic and foreign medical device manufacturers. Karen is an ASQ Certified Biomedical Auditor (CBA) and Certified Manager of Quality/Organizational Excellence (CMQ/OE). Karen earned an MBA from Northwestern University’s Kellogg School of Management and holds a BS in Chemical Engineering, also from Northwestern.
Topic: Developing Talent – Developing Quality Competencies of First and Early Career Individuals.

Speaker – Daryl Bechdolt
https://www.linkedin.com/in/darylbechdolt

3e9d650Daryl Bechdolt will provide an overview of Schneider Electric’s Continuous Improvement Development program branded “El CID”. The targeted three-year program offers early   career and college graduates a chance to develop quality and continuous improvement competencies and learn from experienced continuous improvement belts. Daryl will review the structured process which provides the participants a roadmap and toolkit to advance their careers while adding value to Schneider Electric.


Registration is Closed