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Streamlining Regulatory Compliance Activities Using Product Categorization: A Practical Approach

Diverse product portfolios present unique regulatory challenges, requiring an understanding of compliance requirements for multiple regulatory areas. Treating a diverse product portfolio as if its compliance requirements were homogeneous results in a heavier regulatory burden (and associated cost) on products that have fewer requirements. However, treating each product as distinct results in a loss of efficiency and can also increase costs. Categorizing products based on similarity of regulatory requirements can facilitate streamlining the compliance processes, but striking the right balance between lumping and splitting products requires an understanding of both the regulatory drivers and the products themselves. In this interactive session, the evolution of a product categorization approach at a global laboratory reagent manufacturer will be discussed, followed by an opportunity for attendees to categorize diverse product portfolios from various market sectors and compare the approach taken by others to categorize similar products.

Presenter(s): Tina Armstrong, PhD, Principal Scientist/Associate Vice President, ARCADIS, Melinda Hemingway, PhD, Product Regulatory Affairs Manager, Agilent Technologies, Inc.

Presentation Date: 11/3/2017

Contact Hour(s): 1.5



Your Price: $29.95

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