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

The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the Europe...

The recently revised EU GMP Annex 11 and Chapter 4 (which have been adopted for international use by PIC/S) are also covered. As well as the Europe...

** Permanently Retired Due to Lack of Enrollment **

Why is the Quality Metrics Initiative so important? What are the latest ...

Do you have a framework for a risk-based approach for maintenance systems or component best practices?

Maintenance programs have long been ...

Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part ...

Effective project progress, monitoring, and control are not regulatory issues, but are necessary for the efficient operation of a company and part ...

** 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...

** Permanently Retired Due to Lack of Enrollment **

The prevention of drug shortages is critically important to public healt...

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and...

This course will focus on airborne contaminants and begin by discussing the definition, history, and rationale for the containment of compounds and...

Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure succes...

Calibration is an essential element in ensuring compliance in the pharmaceutical and associated regulated life science industries. To ensure succes...

This course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants w...

This course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants w...

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