Biotechnology Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will discuss requirements for supplier and vendor qualifications. Attendees will learn how to develop a risk management plan for monitoring of suppliers, vendors and service providers. It will also discuss how to prevent recalls and advisory notices due to provided non-conforming materials or bad services.

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

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.

The webinar will discuss best QC practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

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 session on conducting effective GMP trainings will cover proven learning techniques for technical and compliance related trainings. It will answer key questions about how to make GMP training sessions more engaging and even fun for the learners in your organization.

This training will outline the best practices in responding to a FDA Warning Letter so the consequences of the findings do not escalate beyond the current status.

This webinar will highlight the evidence normally requested during audits and inspections of biotechnology analytical labs. You will learn how your laboratory's biotechnology analytical methods can fulfill stated or implied regulatory requirements (the US FDA refers to these as the “C” in CGMPs).

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

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 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 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.

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.