Managing the Drug Supply Chain: Best Practices

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This all-new management report from FDAnews helps you keep tabs on suppliers from Boston to Bangladesh. Supplier qualification and quality agreements. Timely and effective audits. These are but two of the dozens of key topics covered in Managing the Drug Supply Chain: Best Practices. You'll discover procedures you can implement now that ensure the strength of each supply-chain link for years to come. Here's a sampling —

Quality Agreements

  • How to determine which vendors, beyond API providers, need quality agreements

  • Key provisions, essential definitions and general formats for quality agreements

  • What FDA and EU regulators expect to see in a quality agreement

  • Tips for negotiating an agreement

  • Potential agreement pitfalls and how to avoid them, including frequently overlooked details of supplier quality agreements

  • Special challenges in creating quality agreements with overseas suppliers

Supplier Risk Assessments and Audits

  • How to perform supplier risk assessments to determine which suppliers to audit

  • Considerations for developing a supplier risk assessment tool

  • Techniques for building an audit schedule that makes the most of tight budgets

  • Tips for selecting and training auditors

  • Sample auditing frequencies using risk-based selections

  • Relevant guidance for supplier audits

  • How to conduct a supplier audit and write effective audit observations

Upcoming Track & Trace Requirements

Also included in the report is the timetable for the new U.S. track and trace requirements under the Drug Supply Chain Security Act (DSCSA) — and a special section on how to comply with the 2015 DSCSA requirements, as well as upcoming (and even stricter) 2017 and 2023 requirements.

So, there's no time like NOW to begin reviewing and improving your supply chain management — from A-Z.

Let FDAnews and its team of experts act as your guides. Order Managing the Drug Supply Chain: Best Practices TODAY.

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PDF Edition


Disclaimer: The following presentation reflects the personal views and thoughts of the speaker. The content is solely for the purposes of discussion and illustration, and is not to be considered legal or regulatory advice. Speaker is providing this presentation, as is, as a service to interested parties. GS1 US shall not be liable for any consequential, special, indirect, incidental, liquidated, exemplary or punitive damages of any kind or nature whatsoever, or any lost income or profits, under any theory of liability, arising out of the use of this presentation or any content herein, even if advised of possibility of such loss or damage or if such loss or damage could have been reasonably foreseen. GS1 US reserves the right to change the material at any time.

Available Format

PDF Edition — $397

Table of Contents

  • Introduction
  • Selecting the Right Suppliers
  • Contractual Agreements
  • Auditing Suppliers
  • And More …

View the entire TOC

Who Will Benefit

  • Drug company executives
  • Drug manufacturing plant managers
  • Supply chain managers
  • Drug labeling teams
  • Packing and shipping managers
  • Quality managers
  • Regulatory affairs officers
  • Drug wholesalers and distributors
  • Pharmacy managers
  • Hospital officials
  • IT managers
  • Strategic planning staff
  • Pharmaceutical and cGMP auditors
  • Risk management specialists
  • Compliance officers
  • Consultants

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