06. December 2018 - 18:00 till 21:30

Quality program for successful, compliant outsourcing using risk-based tools | DoubleTree by Hilton Hotel San Francisco Airport North | Thursday, 06. December 2018

When your task is US and EU regulatory approval of a greenfield biologic drug substance in Asia, where do you start? What are the quality attributes required in external manufacturing?
What are the responsibilities of the Contract Manufacturing Organization (CMO) vs. the sponsor site? What Quality Risk Management tools do you employ?
Learn about the requirements, contingencies and other areas of concern when completing a tech. transfer from the ground up. Key activities and risk based plans will be highlighted.
The Quality work and oversight resulted in successful FDA and EMA inspections and ultimately licensure of the CMO site. It is a story to learn and build from and reviews many factors needed in the ultimate success in external manufacturing partnerships and quality.
Speaker:

John McShane is a Managing Partner at Validant, based in San Francisco. John brings extensive experience in Quality Systems and remediation with a track record of comprehensive quality performance to joining Validant, John most recently served as a Director in External Biologics Quality Assurance at Roche for four years. In this capacity, John led the Quality efforts on outsourcing of major biologics to two contract manufacturers in Asia. Working with Samsung, he led comprehensive Quality System improvements, and drove extensive inspection readiness initiatives, resulting in Samsung receiving zero observations in their first FDA PAI.
Additionally, John held a previous role as Head of Biologics Quality System for Roche. In this position, and earlier positions at Genentech and Abbott, John helped design the corporate Quality System in compliance with world wide Health Authority expectations across all major global markets and diverse product portfolios. As part of these positions, he led critical Quality efforts such as interim Quality Site Head interfacing with Health Authorities and executing a Quality Improvement Plan, warning letter remediation, Quality integration of new sites and corporate Quality improvement in tank management.
Previously, John held various Quality Assurance, Operations, Technical Support and Project Management roles of increasing responsibility with Abbott, Genentech and Roche. He received his Bachelor of Science degree in Chemical Engineering from Purdue University and his Masters in Business Administration from the University of Chicago.
Expertise: Quality System design and implementation, Quality remediation at the site and corporate level, Validation, FDA, EMA, ICH, PICs
Agenda:
6:00 PM  Registration/Networking*
7:00 PM  Complementary Dinner (buffet style)
7:45 PM  Announcements
8:00 PM  Presentation/Q&A
9:30 PM  Closing
Employees from the following companies are attending the event:

FAQs
How can I contact the organizer with any questions?
You can contact the event organizer sending an email to rsvp@wccpda.org, please allows few days for the respons.
Is my registration fee or ticket transferrable?
Yes, thicket is not reboundable, however you can transfer it to whoever would like to attend in your behalf
What is the dressing code?
Business casual