Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

Description

The Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutionsis dedicated to Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment.

The Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutionscovers topics such as:

  • The impact of raw materials in the timely production of a product
  • How various types of raw materials may impact the user
  • Sources of analyses assistance for raw materials
  • The single most used raw material in large molecule production and what it means to the user
  • Initiation of additional testing -- when?
  • Requirements for Phase 1 through commercial manufacturing
  • Why use compendial testing in lieu non-compendial testing
  • Examination of regulatory risk (ICH Q9)
  • The impact of ASQ on sample size and attribute testing
  • Testing requirements -- when is enough?

The Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions 2017 brings together:

  • Regulatory professionals
  • Quality professionals
  • Manufacturing engineers
  • Compliance professionals
  • Quality auditors
  • Quality engineers
  • Microbiology
  • Quality Control
  • R & D
  • Document control specialists

Future Events

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions 2020

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