Communities of Practice

Retrospective Validation
Wednesday, 26 Oct 2016 19.10

Cleaning Filling Equipment for Multiple Products
Wednesday, 26 Oct 2016 19.10

Safety of manways
Wednesday, 26 Oct 2016 19.10

Rouge - impact on conductivity meassurement ?
Wednesday, 26 Oct 2016 19.10

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Guidance Documents

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2017 Facility of the Year Award Submissions

Upcoming Events

25 Oct
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2016 Process Validation Statistics Conference
Bethesda, MD USA

Dates: 25 Oct 2016 - 27 Oct 2016

31 Oct
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2016 Copenhagen Training
Copenhagen, Denmark

Dates: 31 Oct 2016 - 02 Nov 2016

01 Nov
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2016 ISPE Training Institute - November
Tampa, FL USA

Dates: 01 Nov 2016 - 30 Nov 2016

06 Nov
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2016 Pharma Expo
Chicago, IL USA

Dates: 06 Nov 2016 - 09 Nov 2016

14 Nov
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2016 Facilities of the Future Conference
Bethesda, MD USA

Dates: 14 Nov 2016 - 15 Nov 2016

01 Dec
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2016 ISPE Training Institute - December
Tampa, FL USA

Dates: 01 Dec 2016 - 31 Dec 2016

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ISPE Initiatives

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

ISPE has been leading the charge in bringing the pharmaceutical industry and regulators together to create an open dialogue on shaping the Quality Metrics program as it is launched industry wide. Learn more about this initiative and how it is impacting the pharmaceutical industry.

Drug Shortages
The prevention of drug shortages is critically important to public health. ISPE has been instrumental in facilitating communication between the different sectors of the pharmaceutical industry and global health authorities related to drug shortages.

Learn about the tools available to help you assess your supply chain, identify potential gaps and analyze your findings. In addition, learn about the latest developments related to the drug shortages initiative, why this initiative is so important and what you can do to make an impact in the pharmaceutical industry.

Product Quality Lifecycle Implementation® (PQLI®)
PQLI is ISPE’s Global Industry Initiative for a practical approach to implementation of International Conference on Harmonization (ICH) guidances Q8 (R2), Pharmaceutical Development; Q9, Quality Risk Management; Q10, Pharmaceutical Quality System; and Q11, Development and Manufacture of Drug Substances.

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ISPE's signature training, the type usually delivered over two to three days in a distant classroom, now available from your home or office.


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Pharmaceutical Glossary

Germ Line
A lineage of “generative” cells (= germ track) ancestral to the gametes (sperm and egg cells pro ...