Online Learning Courses

Training
$775 Savings by Purchasing All Three Courses Overview ISPE is presenting a three-part series that will focus on an introduction to Large Molecules and the Chemistry, Manufacturing, and Controls (CMC) aspects of biopharmaceutical development with an emphasis on how they differ from traditional small...
Training
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...
Training
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...
Training
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...
Training
This online course provides an overview of success factors for Commissioning and Qualification projects. It examines key planning steps at the program level and important system level activities that occur prior to construction. These activities define the critical attributes and acceptance criteria...
Training
This highly-interactive, pre-recorded online course reviews the laboratory control system and its importance within the USFDA Systems Inspection Approach, as well as the roles and responsibility of the quality control unit. This online course introduces laboratory controls, breaks down GMP Part 211...
Training
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.
Training
This online course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals, and medical devices. It does not cover the detailed requirements of 21 CFR...
Training
This course, the third in a four-part series, has been designed by ISPE and UL EduNeering, in cooperation with the Food and Drug Administration (FDA)/Office of Regulatory Affairs ORA, to assist FDA personnel in recognizing the critical aspects of computerized systems in the pharmaceutical industry...
Training
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...