Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions: 2-day In-person Seminar

Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

This highly interactive two day seminar on raw material requirements in a cGMP environment will:

The objective of this two day highly interactive ComplianceOnline seminar is to explore raw materials and their requirements - issues and solutions. It will also explore how water impacts the final product since water is the single largest raw material that is used within most processes. Another objective is to assure that your organization is maintaining itself within a cGMP compliance framework to include ICH Q7, Q9 and Q11. Case studies to include Warning Letters will be discussed to illustrate regulatory raw material issues.

Learning Objectives:

Upon completing this course on raw material requirements in a cGMP environment participants will:

Who Will Benefit:

Agenda:

Day 01

Day 02

For more information about this conference visit https://www.researchandmarkets.com/research/sm82vs/raw_material?w=5

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