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

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