Conference & Events
Event Details
Debottlenecking Downstream Operations through Real-Time Re-Use Verification
This webinar will discuss on how to leverage regulatory guidances such as ICH Q9 and ASTM E 2500, will enable a reduction in time and effort of prospective and concurrent re-use validation.
Date: 18 November 2009 10:00 - 11:30
Event Subject(s):
Analytical
Biosciences
Education
Venue
Online Webinar
United States of America
Organiser Information
Organiser(s): ComplianceOnline
Contact for Event Information
Name : Mr Admin
United States of America
Tel:
+ 650-620-3937
Fax:
+ 650-963-2556
Email:
admin@complianceonline.com
Contact Useful link:
http://www.complianceonline.com
Additional Information
Speaker Information:
Peter K. Watler, Ph.D is Principal Consultant and Chief Technology Officer with Hyde Engineering + Consulting. He has 22 years of GMP biopharmaceutical process experience with a focus on process design, scale-up, implementation and facility design, start-up and qualification. He has prepared 3 license submissions and participated in several FDA inspections and GMP audits.
Dr. Watler was previously Vice President, Manufacturing at VaxGen, where he led the design, construction, commissioning and qualification of a GMP vaccine facility. He was also responsible for managing supply chain and production operations, led the CMC team and prepared submissions for government agencies. He previously spent 12 years at Amgen, leading process development, manufacturing support and overseeing pilot plant operations. He has led teams for technology transfer, scale-up, pre-clinical production and process validation for Neupogen®, Stemgen®, Kepivance® and Infergen®. Dr Walter holds a Bachelor’s and a Master’s degree in Chemical Engineering from the University of Toronto and a Ph.D. in Chemical Engineering from Yamaguchi University, Japan.
Useful link:
http://www.complianceonline.com/ecommerce/control/train...
