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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA West Coast Chapter External Manufacturing, Quality, and Technology Transfer Dinner Event

Dec 06 - Dec 06, 2018 |
Dec 06, 2018 |
DoubleTree by Hilton Hotel San Francisco Airport North | Brisbane, CA
  • Chapter
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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.

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 overall quality performance improvement. Before 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 overall Quality System improvements, and drove great 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 worldwide 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.

Since 2008, John has been an active PDA Member and co-authored "PDA's Technical Report 60 Process Validation: A Lifecycle Approach".

John holds a Master’s Degree in Business Administration from the University of Chicago and a Bachelor’s Degree in Chemical Engineering from Purdue University.

  • 6:00 p.m. Registration and Networking
  • 7:00 p.m. Dinner
  • 7:45 p.m. Announcements
  • 8:00 p.m. Presentation and Q&A
  • 9:30 p.m. Closing Remarks

Early Bird Registration (ends December 6)

PDA Member - $50.00 (+ $4.67 FEE)

PDA Non-Member - $45.00 (+ 4.37 FEE)

Alternative Payment Options

  • Check Payments: Make checks payable to "WCC PDA"
  • Email Requests: Submit registration requests to the PDA West Coast Chapter with "WCC PDA Dinner RSVP" as the subject line. Please provide the full name and company affiliation for each registrant.

Cancellation Policy

Dinner seating is confirmed and reserved in advance. The chapter reserves the right to cancel a dinner meeting if the minimum number of attendees is not met by Monday, November 26th.

Refunds will not be accepted for this event. However, we accept name substitutions.

This event will be hosted at Double Tree by Hilton Hotel San Francisco Airport North, located at:

5000 Sierra Point Parkway

Brisbane, CA 94005

 Additional Information

Business casual attire recommended.

Interested in sponsoring this event?

Please send an email to rsvp@wccpda.org with "Sponsor" in the subject line.

 

Ask about our Gold, Silver, and Bronze sponsorship levels.

Register Now
https://www.eventbrite.com/e/quality-program-for-successful-compliant-outsourcing-using-risk-based-tools-tickets-52078964585?aff=eac2

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