"Biotech and drug regulations related compliance training delivered by leading experts through webinars. This section contains compliance training affecting to biotech industry in areas - microbial excursions, Cell Culture, Water System Compliance, USP 111, GMP Bioassays, GEP, QbD, E2500 and Sterilizing Grade Filter Validation."
This webinar will help you understand the process, requirements, quality and safety considerations for demonstrating biosimilarity to a Reference Product. You will learn about what type and how much clinical data are needed to support a showing of biosimilarity.
This webinar will help you understand the significant differences between qualification and validation of an analytical method, the expectations and requirements of each, and their place in the analytical method lifecycle.
This webinar presents a best practices approach for preparing, characterizing and storing cell banks used for GXP analytical and bioanalytical test methods. It covers critical topics such as timelines for generation of cell banks, equipment, growth conditions, purity, consistency, and stability.
Instructor : Ana MenendezLiveThursday, June 21, 2012
This 90-minute webinar will show how to select the best technology and format combination to develop a compliant immunogenicity binding method, and provide a check-list that itemizes all the requirements to develop a compliant validation protocol.
Instructor : Ana MenendezLiveThursday, July 26, 2012
This webinar on lyophilization technology will provide you the understanding required to develop an optimized, cGMP compliant formulation that is specifically designed for lyophilization.
This webinar will discuss various container closure systems that are available for use with liquids and lyophilized products, the components that constitute a container closure system and also cover specialized delivery systems.
This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.
This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.
This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
Mike Morley
Mike Morley is a Certified Public Accountant who holds the top credit designations in the U.S., Canada, and the U.K. Mike is a recognized authority in the field of finance with more than 25 years experience in both consumer and commercial credit and collections. Mike is the author of 2 books that are currently available: Sarbanes-Oxley Simplified, is an easy-to-read explanation of the requirements of the U.S. legislation. Credit & Credit Repair for Canadians, which explains how the Canadian Credit industry works.
