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IVT’s 3rd Annual Forum on Supplier Quality

Establish Best Practices to Address Supplier Qualification, GMP Audits and Increased Regulatory Requirements in the Life Sciences Industry

November 8-9, 2012
  • Philadelphia, Pennsylvania

Available for $298.00

Establish Best Practices to Address Supplier Qualification, GMP Audits and Increased Regulatory Requirements in the Life Sciences Industry
Global regulatory agencies (inclusive of U.S., EU, China and India) have begun to tighten international oversight on supply chains, which continue to evolve and become more complex. With all the intricacies and nuances within a supply chain, audits are increasingly necessary throughout drug, biologic or device manufacturing to ensure supplier compliance worldwide.  Join this unique forum that addresses supplier quality management and GMP compliance at a global level. During this conference, hear from industry thought leaders, discuss best practices to ensure suppliers comply with and enforce GMP guidelines.

Topics for discussion include:

  • FDA and EMA harmonization efforts and regulatory requirements for supplier audits and GMP inspections
  • The qualification criteria for internal and 3rd party auditors
  • Risk management programs for biopharmaceutical and medical device companies
  • Standard GMP’s for Excipient and API suppliers
  • Technology software for new or existing vendors
  • Supplier audit protocol:
    • pre-audit, on-site and post-audit
  • Track and manage the pedigree and supply chain of supplier materials
  • And more