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About

Join us to learn about the measures drug manufacturers must take to comply with regulatory requirements; the best practices for selecting and working with excipient suppliers; and the challenges with excipient testing programs.

Starts

September 20, 2016, 11:00

Ends

September 20, 2016, 12:01

Location

Online

In this webcast, experts will review measures drug manufacturers must take to comply with regulatory requirements; outline best practices for selecting and working with excipient suppliers; and explain challenges with excipient testing programs including compendial method verification.

Event Overview

Excipients are used in most drug products and the quality of the materials, manufacturing processes, and test methods are vital to the production of safe, effective therapies. While industry guidances, excipient monographs, and compendial test methods provide some direction, sourcing and testing of excipients is an ongoing challenge for drug manufacturers.

A complex supply chain, raw materials quality concerns, and lot-to-lot and supplier-to-supplier variability are just some of the factors that can affect the consistency of excipient quality and performance. Routine testing of excipients, therefore, is crucial. Drug manufacturers must not only verify compendial test methods, but also assess the suitability of these test methods to meet the requirements of excipients, manufacturing processes, and analytical instruments currently used.

In this webcast, experts will review measures drug manufacturers must take to comply with regulatory requirements; outline best practices for selecting and working with excipient suppliers; and explain challenges with excipient testing programs including compendial method verification.

Key Learning Objectives

  • Understand the potential for contamination and variability in the excipient supply chain
  • Review regulatory requirements and compendial guidance documents
  • Discuss best practices for selecting and monitoring excipient suppliers
  • Understand challenges with excipient test methods and the importance of compendial method validation

Who Should Attend

  • Quality control managers
  • Lab managers
  • Drug formulation experts
  • Regulatory affairs professionals