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...

Why is the Quality Metrics Initiative so important? What are the latest developments? How can I participate and make an impact in the pharmaceutica...

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

Maintenance programs have long been ...

GSK Training

This presentation describes the various problem areas relating to GMP in the Asia Pacific region, particularly the various GMP problem areas that c...

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 ...

This course has been designed to assist FDA inspectors in recognizing the critical aspects of computerized systems in the medical device industry. ...

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...