Education Session

303 - Ensuring the Integrity of the Global Supply Chain

10 November 08.15-11.30
ISPE CEUs: 0.23

Get Agenda Tracks: SurvivalRegulatory Supply

Sponsored by the ISPE Commissioning and Qualification Community of Practice (COP)

Ensuring the integrity of the pharmaceutical supply chain has recently become a focus area for industry and regulators. Over the past several years, the supply chain has become more complex, the opportunities for economically motivated adulteration have increased. Consequently, the industry is facing increasing legislative scrutiny and guidance on ensuring the quality of its products throughout their entire lifecycle. The FDA, the European Commission, and WHO have issued recent guidance documents to address these challenges while regulatory agencies around the world are in the process of reviewing their regulations in an attempt to assure safe, efficacious drug supply from the manufacturer to the final delivery to the patient.

How you will Benefit

At the end of this session, participants will be able to:

  • Understand the regulations and guidance relating to supply chain management and anticounterfeiting
  • Describe anticounterfeiting measures
  • Develop a quality management system for assuring supply chain integrity and for ensuring public health and safety
  • Design auditing programs for suppliers, distributors and shippers

Who Should Attend

Professionals from logistics and distribution, purchasing, warehousing, manufacturing, quality assurance, regulatory affairs, research and development, senior experts, corporate security, regulators, suppliers, and patient organizations (pharmacists, physicians, and distributors)

ISPE Communities of Practice (COPs)

API, Biotech, C&Q, Containment, ESB, GAMP, GCLP, IP, OSD, Packaging, PAT, PPD, PM, SPP, and SF

View the ISPE Community of Practice (COP) Guide

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