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ISPE GAMP Guide:  Records and Data Integrity

Upcoming Events

01 Jun
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Turning QbD Into a Practical Reality Training Course - T43
Tampa, FL USA

Dates: 01 Jun 2017 - 02 Jun 2017

04 Jun
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2017 ISPE Data Integrity Workshop
Arlington, VA USA

Dates: 04 Jun 2017 - 04 Jun 2017

05 Jun
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2017 ISPE/FDA/PQRI Quality Manufacturing Conference
Arlington, VA USA

Dates: 05 Jun 2017 - 07 Jun 2017

12 Jun
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Basic GAMP 5, Annex 11/ Part 11 Training Course - T45
Indianapolis, IN USA

Dates: 12 Jun 2017 - 14 Jun 2017

12 Jun
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Pharma Water Generation USP WFI & PW Training Course - T04
Tampa, FL USA

Dates: 12 Jun 2017 - 13 Jun 2017

14 Jun
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Storage/ Qualification of Pharma Water Training Course - T23
Tampa, FL USA

Dates: 14 Jun 2017 - 15 Jun 2017

19 Jun
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GAMP 5 GxP Compliance Training Course - T21
Tampa, FL USA

Dates: 19 Jun 2017 - 20 Jun 2017

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Pharmaceutical Glossary

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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.


The Official Information Source of ISPE

A Quality and Innovative Mindset – A Formula for Future Success
Wednesday, 24 May 2017 07.05

FDA, Data Integrity, and the Dreaded Twenty-Five Words
Tuesday, 23 May 2017 07.05

Extractables and Leachables: Not the Same – Part 1
Monday, 22 May 2017 07.05

Career Solutions Jobs

Communities of Practice

Wednesday, 24 May 2017 17.05

Use and paper and computerized system
Wednesday, 24 May 2017 17.05

UK Affiliate Summer Conference on Containment and Decontamination
Wednesday, 24 May 2017 17.05

qualification of water system
Wednesday, 24 May 2017 17.05

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