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John Hyde

Chariman & Founder

JM Hyde Consulting


Speaker Bio

John Hyde is the Founder and CEO of JM Hyde Consulting, Inc., a firm of 100 professionals specializing in providing process systems design, commissioning, validation and FDA compliance services to biopharmaceutical and pharmaceutical manufacturers. Prior to the formation of JM Hyde Consulting, Mr. Hyde was a Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities. From 1982 to 1992, Mr. Hyde was Manager, Process Systems Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of pharmaceutical, dairy and food process systems and the application of CIP technology.
Mr. Hyde has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, cleaning and cleaning validation principles and practices, FDA compliance strategies, and control systems design for manufacturing processes. He has published ten articles on these subjects. Mr. Hyde served as a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation and in this capacity he contributed two chapters to a book on the subject. Mr. Hyde serves on the board of the Society of Bioprocess Professionals (SBP) and he is a regular speaker on conferences presented by SBP, ISPE, PharmaConference, IVT, Microrite and other professional societies. He holds Bachelors degrees in Food Science and Business Administration, and a Masters degree in Food Engineering, all from the Ohio State University

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Wednesday, April 21, 2010
Conference Program
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Using ICH Q9 and the New Process Validation Guidance as the Foundation for the Planning, Development and Execution of Risk-Based Process and Cleaning Validation Studies
Room: 1E16 ~ 11:30AM - 12:30PM (Wednesday, April 21, 2010)
This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices. Specific topics to be discussed include the following: • Review of industry current best practices and future trends for cleaning validation studies • Review of ICH Q9 content with respect to cleaning validation • Presentation of practical cleaning validation risk analyses and management tools • Review of recent FDA comments and observations on risk-based validation • Evaluation of the role of PAT in risk-based cleaning validation studies • Review of Statistical Process Control (SPC) methodologies for ongoing monitoring of cleaning operations
Speaker:
John Hyde - Chariman & Founder, JM Hyde Consulting

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