Online Learning Courses

This online course will explore the pros and cons of cloud-based computing. Attendees will gain an understanding of what "the cloud" is and how it's both different, and similar, in comparison to software solutions that run on company-owned servers. Data concerns will also be addressed and aspects of...
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...
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...
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...
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...
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...
The prevention of drug shortages is critically important to public health. As a not-for-profit global organization with both industry and regulatory members in 90 countries, ISPE is uniquely positioned to facilitate...
This highly interactive pre-recorded online course reviews the Facilities and Equipment Systems and their importance within the USFDA Systems Inspection . The Facilities System elements examine the general regulations...
US FDA’s Draft 2008 Process Validation Guidelines provide an excellent framework for understanding Process Validation . They describe the principles and approaches that the FDA feels the industry should use in executing...