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News & Events

PDA Conference - Berlin

Friday 05 December 2014

The PDA Conference on Managing Outsourcing / Contract Manufacturing Operations was held in Berlin, 02-03 December 2014. DPS’s Cory Siddons was invited to speak regarding Design Solutions for Aging Facilities.

The objective of this conference was to discuss trends and regulatory requirements regarding outsourced operations for FDA and EU regulated companies. Topics discussed included:

  • General trends in outsourcing and “partnersourcing”
  • Regulatory updates (EU revisions to Chapters 1 and 7, FDA 21 CFR 200.10(b), and FDA guidance on quality contracts)
  • Format and content of Quality Agreements
  • Tech transfer
  • Role of PIP (person in plant)
  • Transition from Phase I/II to commercial manufacturing
  • Customized solutions, equipment, and facility issues

Cory’s presentation was focused on Design Solutions for Aging Facilities, in particular from the perspective of the CMO (Contract Manufacturing Organization). Companies are more often faced with managing and maintaining aging or legacy assets, either within existing facilities or through site consolidation. At the same time, regulators continue to closely evaluate these legacy facilities, ensuring that appropriate upgrades and modernization occurs, and that facility and equipment upgrades continue to be grounded in a risk-based and data-driven evaluation.   The scope of the discussion included:

  • General discussion of aging global facility infrastructure
  • Challenges with aging facilities
  • CMO perspective on aging facilities
  • Considerations on planning and design
  • Example tools and techniques, including Facility Gap Analysis, Capacity Analysis, Facility Risk Assessments, and the Design Lifecycle
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