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...

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...

** 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...

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...

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tri...

This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tri...

Airflow pattern visualization provides a visual record of actual airflow patterns in a pharmaceutical facility.  It is currently the most wide...

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...

ISPE is presenting a 3 part series that will focus on an introduction to the Chemistry, Manufacturing and Controls (CMC) aspects of biopharmaceutic...