"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 Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals.
Instructor : Ana MenendezLiveThursday, March 8, 2012
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.
Instructor : Ana MenendezLiveThursday, February 23, 2012
This webinar on the draft FDA Guidance for Immunogenicity Testing will cover recommended approach to design elements of assay development and validation parameters.
This cGMP training will helps you in understanding systematic plan of evaluating cGMP applicable to the IND product cycle, the regulatory mandates (FDA, ICH, CHMP and the EU medicine agency), risk-management strategy and potential consequences for failures in inadequate assessment, and case studies of infractions.
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 vendor qualification training will provide valuable assistance on how to avoid costly regulatory action from agencies when they inspect your facilities in pharmaceutical and biotech industries and find deficiencies in your vendor qualification programs. It will show you how to assess your systems and bring them into compliance.
This 4-hr lyophilization cycle webinar will cover all aspects of freeze-drying, primary and secondary drying processes, critical issues in scale-up or cycle transfer, and show how to troubleshoot, diagnose, and correct failed batches of products.
The webinar will explain how the pharmaceutical industry stakeholders can build and institutionalize risk management processes across the end-to-end supply chain, to secure compliant, risk mitigated supply chains able to compete on a world stage in terms of quality, cost and delivery performance.
This 4-hr lyophilization webinar will cover all of the aspects of understanding a freeze-dryer, the justification for freeze-drying, the thermal properties of the formulation (crystalline, amorphous, mixed), the analytical techniques employed to characterize these systems, and how all of this information is used to develop a stable, optimized, cGMP compliant product.
Dan Swanson
Dan Swanson CMA, CIA, CISA, CISSP, CAP President and CEO, Dan Swanson & Associates is a 24-year internal audit veteran, who most recently was director of professional practices at the Institute of Internal Auditors. Prior to the IIA, Swanson was an independent management consultant for over 10 years.
