Online Learning Courses

After a history of tragic events that affected public safety, the current Good Manufacturing Practices (GMPs) were developed. GMPs are a set of regulations that uphold the Federal Food, Drug, and Cosmetic Act. It is important to look back at the history of these events, their effect on public health...
The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the...
To ensure pharmaceuticals meet specifications and regulatory requirements, manufacturers must create, implement, and follow quality systems. A “Quality System” is blueprint for a pharmaceutical manufacturer. It outlines quality philosophies and processes, provides details about how people work...
Modo de Entrega: Webinar Produtos Biofarmacêuticos: Webinar de Introdução a Grandes Moléculas Visão geral Este webinar é uma gravação do novo curso ministrado por instrutores que introduz os participantes ao desenvolvimento de biofármacos e abordará conceitos que destacam as diferenças entre...
$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...
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...
This online course 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 Part 11, except for the...
This course 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 during Pre-Approval and routine...