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ISPE GAMP Guide:  Records and Data Integrity

Upcoming Events

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08 May
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2017 ISPE Pharmaceutical Serialization Workshops
Philadelphia, PA USA

Dates: 08 May 2017 - 09 May 2017

Mon
08 May
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Deployment of Operational Excellence Training Course - T56
St. Gallen, Switzerland

Dates: 08 May 2017 - 09 May 2017

Mon
08 May
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Pharma Water Generation USP WFI & PW Training Course - T04
San Diego, CA USA

Dates: 08 May 2017 - 09 May 2017

Mon
08 May
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Biotechnology Mfg. Facility Design Training Course - T31
San Diego, CA USA

Dates: 08 May 2017 - 09 May 2017

Mon
08 May
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GAMP Data Integrity 21 CFR Part 11 Training Course - T50
San Diego, CA USA

Dates: 08 May 2017 - 10 May 2017

Mon
08 May
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HVAC CGMP Regulations Training Course - T14
Copenhagen, Denmark

Dates: 08 May 2017 - 10 May 2017

Mon
08 May
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Cleaning Validation Principles Training Course - T17
Copenhagen, Denmark

Dates: 08 May 2017 - 09 May 2017

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Pharmaceutical Glossary

Btu (British thermal unit)
The unit used to measure the amount of heat in a substance. One Btu is the heat required to produce ...

ISPE Initiatives

Quality Metrics
ISPE is leading the charge to bring industry and regulators together for open dialog and exchange.

Drug Shortages
ISPE’s Drug Shortage Initiative facilitates communication between the pharmaceutical industry and global health authorities to understand and address this complex problem.

Blend and Content Uniformity
An ISPE-sponsored group of regulators, industry, and academia are identifying alternative approaches to assess Blend and Content Uniformity.

Patient Initiative: Survey on Patient Experience with Clinical Trial Materials
A global survey on patient experiences with clinical trial materials, including the suitability of packaging, labels, technologies, transportation, and storage.