Biotech Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Water system validation training will guide you on how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system.

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 training provides an up-to-date understanding of regulatory requirements for the development and implementation of biomarkers in drug development programs, as well as highlights of the most recent FDA sources on general, imaging (Including PET) and pharmacogenomic biomarkers.

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 provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.

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 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.

This webinar on Potency Bioassays will show how to implement the parameters described in the new USP Bioassay suite to deliver compliant assays for Phase I/II, Phase III and commercial products.

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

This 3-hr virtual seminar will cover the USFDA's regulation of cell therapies and HCT/Ps, FDA's labeling and promotional rules and the agency's current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

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.

The Objective of this live, interactive training webinar is to explore the various issues surrounding the history of B. cepacia and its Complex and examine solutions to common microbiological problems. It will discuss the General Chapter USP<60> which was issued December 2019, media that is used, as well as consider recalls, FDA 483s and Warning Letters. The webinar will also review why 16S rRNA identification will not work satisfactorily with this Complex. Please plan to bring an interdisciplinary team to this Webinar to explore how knowledge regarding this contaminant may assist you in your facilities and minimize it as an Objectionable microorganism.

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.

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.