A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

Compounding Pharmacy Consultant Christopher J. Smalley is a contributor to the book, A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry. The book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients.

Chris Smalley’s chapter, Identification of Critical Knowledge: Demystifying Knowledgesmalley book Mapping, provides examples of how companies can map their organizations’ knowledge and assess critical knowledge gaps in order to improve access, flow and reuse of critical knowledge by the people who need it, when they need it. Smalley commented, “Tacit knowledge—knowledge based on memory—contributes to making better pharmaceuticals and helps to explain why an operator trained in the procedures and following the batch record might not be successful in manufacturing a satisfactory batch.” He continued, “The challenge for organizations is to capture tacit knowledge and make it institutional knowledge by incorporating it into batch records updates and procedures.”

Chris Smalley works with pharmacists to design, build and operate Smalley Chris 2010 copycompliant compounding facilities. He recently retired from Merck, where he worked for five years on innovative implementation and validation, including Single Use Systems globally. Previously, he was Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier as a plant manger for the Johnson & Johnson family of companies.

Chris has been a member of the Parenteral Drug Association (“PDA”) Board of Directors, as well as a member of the PDA Science Advisory Board. Currently, he is a member of the ISPE Disposables CoP. His chapter for A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry is available at www.crcpress.com.

Chris can be reached at csmalley@valsource.com.