Online Live

Training
This new instructor lead course is an advanced level course on Cell and Gene Therapies C&GT and Advanced Therapy Medicinal Products (ATMP). The course provides an overview of the most common and established components that are leveraged in C&GT products (e.g. plasmids, mRNA, lipid nanoparticles....
Training
This new instructor led course is an advanced level course on Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development. The purpose of this course is to provide an advanced understanding of the CMC considerations of biopharmaceuticals from development to commercialization....
Training
This new instructor led course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and....
Online Live
Online Live Overview Applying the Biopharmaceutical Manufacturing Facilities Baseline® Guide Principles Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the...
Online Live
Online Live Overview This virtual course examines current technology and provides scenario-based exercises for system troubleshooting and investigational events for process deviations, discusses quality management and...
Online Live
Online Live Overview Lifecycle Process Validation (PV) remains one of the most important and commonly misunderstood topics in the pharmaceutical industry. How many lots should I make? Are we taking enough samples? Do we...
Online Live
Online Live Overview This virtual course aims to deliver more than the usual project basics and will develop the concept of the project lifecycle from initiation through to delivery of business benefits, providing tools...
Online Live
Online Live Overview Driven by biopharmaceuticals but also prominent in small molecules drug manufacturing as well as for APIs, aseptic processing will undergo a technology jump start driven by the new EC GMP Guide Annex...
Online Live
Online Live Overview The implementation of Quality by Design (QbD) and Six Sigma within the pharmaceutical industry has led to an emphasis on the importance of companies developing a robust operational control strategy...
Online Live
Online Live Overview This Virtual course includes the new revised EU GMP Annex 11, and an update on 21 CFR Part 11. This two-day fundamental course* introduces participants to regulatory requirements for computerized...