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Sara Rybak, Senior Manager

Charles River Laboratories, United States

Sara Rybak is the Senior Manager at the Charles River site in Skokie, Illinois, United States. Before moving into management, Sara spent several years auditing in the lab sciences group (particularly Genetic and In Vitro Toxicology and Protein Bioanalysis). Prior to joining Charles River, Sara was a Quality Technician in manufacturing at Abbott Laboratoriesí diagnostic division.
Sara has a BS in Chemistry from the University of Wisconsin ñ Madison and is a member of SQA (Society of Quality Assurance). She administers GLP training through SQA's Quality College and is a registered quality professional in GLP (RQAP-GLP).

 


Abstract

Bridging the Gap between New (and not so New) Technologies and the Regulations

Rapid evolution of consumer products and technologies presents a challenge for regulators and industry alike.  As a result, new methodology, equipment, and products are being developed and used in regulated work, often ahead of regulatory guidelines.

The presentation will review the following for two case studies, a consumer product (electronic cigarettes) and technology (flow cytometry):

  • Background of the product/technology
  • Regulatory guidance
  • Industry Approach
  • Considerations for Quality Assurance.

The challenge of performing work in these areas will be discussed from an industry perspective. The presentation will conclude by summarising considerations for Quality Assurance professionals when reviewing this work.

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