The ISPE D/A/C/H Affiliate Handbook: Production of Water for Injection without Distillation was first published by the ISPE Germany/Austria/Switzer...

ISPE Expert Xchange: Next Decade of Continuous Manufacturing

Recording of the Expert Exchange Webinar originally presented June 1, 2022

ISPE Expert Xchange: Regulatory Summit on ICH Q9 Revision

Recording of the Expert Exchange Webinar originally presented on June 9, 2022

International Council for Harmonisation’s (ICH) guideline entitled, “Technical and Regulatory Considerations for Pharmaceutical Product...

International Council fo...

In this course, you will learn the requirements for storage, handling, and distribution of finished products to ensure that they are stored in ...

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices....

This course offers an overview of Good Manufacturing Practices (GMP) for medicinal product production and process control. You will learn about...

In this course, you will learn about the fundamentals and importance of GMP control in the pharmaceutical industry. Good Manufacturing Practice...

This course will focus on the fundamentals and importance of GMP Equipment.

GMP Fundamentals: Buildings and Facilities

This course will focus on the fundamentals and importance of a GMP Quality...

The Code of Federal Regulations (CFR) states: "Each person engaged in the manufacture, processing, packing, or holding of a drug product shall ...

This course will focus on an introduction to History, Regulations, Product life-cycle, and development with an emphasis on the difference betwe...

In this course, you will learn the various types of documentation and record-keeping practices used in the pharmaceutical industry, and how to ...

In this course, you will learn about the fundamental principles of laboratory controls in Good Manufacturing Practice (GMP). You will understand th...

** Permanently Retired Due to Lack of Enrollment **

This course has been designed to assist FDA inspectors in recognizing th...

This course describes an approach to the validation and compliance of computerized systems used in the manufacture of pharmaceuticals, biologicals,...

This course, the first in a four-part series, describes regulatory requirements and expectations regarding the validation and compliance of compute...

Bem-vindo ao Biofarmacêuticos: Aspectos CMC. A ciência e a tecnologia de desenvolvimento e fabricação biofarmacêuti...

O curso se concentrará em aspectos de Introdução à Química, Manufatura e Controles (CMC) do desenvolvimento biof...

The course will focus on an Introduction to Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutical development and a secondary em...