February General Meeting 🗓 🗺

Wednesday, February 10th, 2016

Venue:

White Eagle Banquets
6839 North Milwaukee Avenue
Niles, IL 60714

Agenda:

  • Doors Open: 5:30 PM
  • Pre-Dinner Session: 6:00 PM
  • Dinner: 7:00 PM
  • Post Dinner Session: 8:00 PM
  • Adjourn: 9:00 PM

Dinner Menu:

Family Style

  • Roast Chicken with Golden Sauce
  • Roast Brisket of Beef with Brown Gravy
  • Vegetable Francais
  • Mashed Potatoes
  • Ice Cream Sundae w/Chocolate Topping

Cost:

  • ASQ Members: $30
  • Non-Members: $30

Pre-Dinner Synopsis:

Data Integrity Compliance, Electronic Records and Signatures Management, Computer Systems and Spreadsheet Validation

Download the Presentation: ERES and Data Integrity ASQ Kriti Chopra 2016

Presenter:

3f8adfaKriti Chopra, Validation Engineer, Hospira – A Pfizer Company, has been working for over 5 years in pharmaceutical industry, with specialized interest in Data Integrity Assurance, 21 CFR Part 11 and Computer Systems Validation. Kriti’s work includes establishing standardized approach and requirements for Computer System Validation and Spreadsheet Validation, developing tools for assessing quality systems, identifying risk associated with GxP systems, planning remediation activities, developing global compliance programs and training related to data integrity and security, preparing responses to FDA observations, and supporting data integrity audits.

Since 2014, Kriti has been involved in successfully establishing a Validation Community of Practice (CoP) at Hospira-Pfizer and a Center of Excellence (CoE) for Computer System Validation (CSV), Spreadsheet Validation (SSV) and Data Integrity Compliance. Kriti’s most recent interests include global implementation of data integrity and security controls that are robust, cost-effective and ensure that the usage of computer laboratory systems, manufacturing systems and spreadsheets is compliant with FDA, MHRA and EU requirements. Kriti has a Bachelor’s degree in Biochemistry from Michigan State University, a Master’s degree in Biotechnology from Northwestern University, is a member of ASQ, PDA, and ISPE.

Website: https://www.linkedin.com/in/kriti-chopra-277a2921

Post Dinner Synopsis:

Introduction to Reliability

Download the Presentation: ASQReliabilityDivisionIntroPresentation

Presenter:
05c88aeDan Burrows is Reliability Engineering & Test Director for a private company. He is has over 25 years of experience in aerospace, electronics, automated assembly, heavy equipment, and production systems reliability. He holds a Bachelor’s Degree in Mechanical Engineering and a Master’s Degree in Business Administration. He is an ASQ CRE, CSSBB, and CMQ/OE.

Website: https://www.linkedin.com/in/dancburrows

Registration is Closed

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