On Demand Training

This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive biopharma production platform was placed into operation in New Haven, CT in...

This Airflow Pattern Visualization online course provides a unique opportunity to explore the requirements for airflow pattern visualization and to see different video examples of actual airflow pattern visualization results. The course provides a comparison of different types of airflow patterns...

This online course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices that are required to meet FDA’s regulations.

The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This 'digital asset' reflects the value of data that mirrors the physical assets. The genesis of this digital asset (engineering data) is created and collected from...

Basic Principles of Computerized Systems Compliance: Applying the GAMP5® Guide: A Risk-Based Approach to Compliant GxP Computerized Systems This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried...

Biopharmaceuticals: C&GT and ATMP Training Course Overview 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...

Biopharmaceuticals: CMC Aspects Training Course Overview 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: Introduction to Large Molecule Therapeutics Training Course Overview This new online course introduces participants to the development of biopharmaceuticals and it will cover concepts that highlight the differences between small molecules and biomolecules (large molecules). The...

Clean-in-place design integration and cleaning chemical selection are vital components of every pharmaceutical manufacturing process; indeed, all pharmaceutical companies employ some type of cleaning application every day. As a result, FDA inspections of cleaning processes have been occurring with...