Newsletter, February 2017

Dear reader,

 Our next meeting is February 16, 2017

 

The February membership meeting is at

Arboretum Club

401 Half Day Road, Buffalo Grove.

Members and non-members are always welcomed.

There is no charge for people who wish to listen to the speakers and forego dinner.

Although walk-ins are welcome, we strongly urge you to pre-register.

 

Door prizes of wine, books and other great gifts are given out every month.

 

Register for the February Meeting by using the link below:

 

https://www.eventbrite.com/e/asq-section-1212-february-meeting-and-dinner-tickets-27442471170?aff=eac2

 

 

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Pre-Dinner Meeting:

Presentation Topic:   Taking the Mystery out of Computer System Compliance by Deb Bartel

The aim of this presentation is to increase the comfort level on the subjects of computer system validation and electronic data integrity by answering these questions:

  • What is Computer System Validation (CSV)
  • Why should you perform CSV
  • Which systems need to be validated
  • What are the steps of the CSV process
  • What do you need to do to ensure the integrity of electronic data

During Networking Dinner:

CGMP and Postmarketing Safety Reporting Requirements for Combination Products by Jesse Vazquez

Jesse Vazquez from FDA Chicago district office will be present at our meeting to answer questions that our members may have. Jesse is a Medical Device Specialist (Biomedical Engineer / Investigator) at the Chicago district office.

Post-Dinner Meeting: cGMP and post marketing safety reporting requirements for combination products by Mark D. Kramer, MS, RAC

Mark D. Kramer, MS, RAC, is President, Regulatory Strategies, Inc., (www.regulatorystrategies.net), a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration

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