Biologics and Biosimilars Regulatory Compliance Training - Live Webinars, Recordings & CDs

This training program will prepare attendees for new regulatory requirements that will arise and apply to your cell line, even if it was made before the requirements were in place. One of the first steps in a recombinant project is the development of the cell line to produce the protein of interest, generally years before the product will be filed for licensure. How do you peer into the future to make sure that when the day comes to file for approval that you have collected and saved all the necessary information on that cell line and your master and working cell banks? Don’t make the mistake of assuming that you can find all that information years from now – create a plan to ensure everything is documented and saved.

This GLP compliant assay training will help attendees deal with the challenges and pitfalls that may occur when translating assays as demonstrated in the scientific literature or through internal discovery efforts.

This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.

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 90-minute session will cover the basics of freeze drying as it relates to the pharmaceutical, biological and food industries. Specifically, this session will highlight using a scientific approach to developing an optimal formulation and lyophilization cycle for those freeze-drying in these industries.

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 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 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.

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.

This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.

Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts. Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.

This Bioassays training/webinar will systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.

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 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 highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.

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

Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.

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 webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.