Biotechnology Products Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar on objectionable microorganisms will show how to identify and prevent objectionable microorganisms that are beyond the ones outlined in USP <1111>. Attendees will learn the clinical implications due to presence of objectionable microorganisms.

This training will discuss the processes and effects of immunogenicity to biologics and the screening methodologies to measure immune response. Participants will learn how to apply regulatory mandates and about the commercial repercussions of unwanted immune responses.

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 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.

This training will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-dried products in vials, to foods.

This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.

This Water system compliance training will guide you through the changes to implement to Validate Water system and better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

This water compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization.

This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

This Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.

This biotech training will look at different methods to validate the alternate method and Validating of Rapid Microbiological Methods.

This Biopharmaceutical Compliance training provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Designing an effective disinfectant validation program to meet FDA and EMEA scrutiny. This webinar provides guidance on industry trends, regulatory feedback, and designs for an effective validation program. Current 483's, Warning Letters, and Field Experiences will be conveyed that allow end users to determine that best methods to validate their products against their isolates.

This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.

This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.

This Validation training describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews current industry guidelines with a goal to preparing a scientific validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls between various technologies and suggests solutions

This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.

This 90-minute training will provide you with an overview of a forced degradation study on a protein therapeutic and help you interpret and leverage the results to design stability studies required for registration of the BLA.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This Water system compliance training will give you a comprehensive knowledge about water system compliance with relation to Microbial Quality Problems, Microbial Testing, Endotoxin control, Sanitization, Water system validation.