Friday May 18, 2012 Friday May 18, 2012
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| Date: Thursday, March 29, 2012 | |
| Registration Single Attendee: CAD $195.00 Group rates are available. (see below) All rates are subject to the Canadian 13% Harmonized Sales Tax (HST) |
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Time: 1:00 PM ET | 10:00 AM PT | Duration: 1.5 hours |
The new FDA Guidance defines process validation as the “collection and evaluation of data, from the process design stage through commercial production”. This lifecycle approach and the stages 1, 2, and 3 of the guidance will be explained and examined. We will address the latest regulatory expectations and industry best practices for process validation. Tools for each process validation lifecycle stage will be reviewed to provide firms with a compliant and science based program. Process validation extends far beyond testing process streams for yield and purity and includes concepts such as Critical Process Parameters, multivariate analysis, orthogonal analytical methods, justified acceptance criteria and statistical analysis.
We will explore how to apply the FDA’s Guidance on Quality Risk Management (ICH Q9) and PDA’s Technical Report 42 concepts to identify high risk factors. FMEA will be used to identify critical parameters which then streamline the validation effort. The risk analysis will identify high risk elements to be mitigated during stage 1 through Quality by Design practices such as mechanistic and DOE techniques. As validation advances, the risk analysis will become an integral part in justifying parameters to study during the intensive commercial qualification stage. Finally, the risk analysis coupled with statistical process control techniques such as “short-run” SPC, will be used to develop and streamline the ongoing process monitoring program.
This webinar is geared to those are:
Mr. John Hyde is Chairman and Founder of Hyde Engineering + Consulting, Inc., a firm of 100+ engineers and scientists founded in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting has operations in the United States, Europe and India.
For nearly two years prior to the formation of JM Hyde Consulting, Inc., John was 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, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of hygienic process systems and the application of CIP technology.
Hyde has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, automatic cleaning system design and implementation, and control system design for pharmaceutical processes, and he has published ten articles on these topics. He, as a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation, contributed two chapters to a book on the subject, and he is completing a book manuscript on CIP technology. John is a member of the editorial board of the Journal of Validation Technology and he has been a regular speaker on conferences presented by Pharma Conference, the Institute of Validation Technology (IVT), the International Society of Pharmaceutical Engineers (ISPE), the American Institute of Chemical Engineers (AIChE) and other professional societies. John has also provided training to FDA CBER personnel on cleaning and cleaning validation practices. He holds Bachelor’s degrees in Food Science and Business Administration, and a Masters degree in Food Engineering, all from the Ohio State University.
Single Attendee: CAD $195.00
Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00
Single attendee refers to single participant at a single computer/login.
Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.
Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.