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Sustaining Compliance Consistency Throughout Your Supplier Networks (2B)

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Monday, 4 June 2012, 14.00 – 15.30

Moderator: Michael Arnold, R.Ph., Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies, USA

Over the past several years, the pharmaceutical industry has outsourced more and more of their manufacturing, packaging, and distribution operations. In the past, the objective was "focus on the core" and externalize the rest. We are now at a point where most operations are at least considered for outsourcing and many of them fall into the outsourcing bucket. With this increased emphasis on outsourcing, there is an increased need for effective monitoring of compliance parameters, product risk and quality controls. This session will explore ways to ensure compliance of your providers and ultimately protect the integrity of your product.

At the conclusion of this session participants will be able to:

  • Understand the compliance risks associated with supply networks
  • Know what signs to look for in assessing these risks
  • Identify ways to monitor and measure compliance of your suppliers
  • Manage compliance with a higher level of confidence

Session Agenda 

14.00 – 15.30
Sustaining Compliance Consistency Throughout Your Supplier Networks
Session Moderator: 
Michael Arnold, R.Ph., Senior Director, Strategic Partnerships, Pfizer Global Clinical Supplies

14.00 – 14.30
Managing CMO's – Assuring Compliance with Your Outsourced Supply
Cathy Burgess, Partner, Alston & Bird LLP

14.30 – 15.00
Critical Supply Chain Issues - Vendor Audits on Single Use Disposable Systems and the Sterilization - Lessons Learned
Ken Baker, CEO, AdvantaPure
Bill Keiser, Quality Assurance, AdavantaPure

15.00 – 15.30
Industry and Regulatory Q & A Panel

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