Issues and Solutions 2021 - Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

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,
The objective of this FIVE HOUR/DAY, ON-LINE two day highly interactive WCS 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.
Understand how various types of raw materials may impact the user.
Learn of the impact of raw materials to include any bacterial and endotoxin issues in the timely production of a product.
Determine the single most used raw material in large molecule production and what it means to the user.
Speaker:
Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance