ISPE GAMP Guide:  Records and Data Integrity

Upcoming Events and Training

Sun
04 Jun
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2017 ISPE Data Integrity Workshop
Arlington, VA USA

Dates: 04 Jun 2017 - 04 Jun 2017

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

Dates: 05 Jun 2017 - 07 Jun 2017

Tue
12 Sep
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2017 Process Validation Conference
Bethesda, MD USA

Dates: 12 Sep 2017 - 14 Sep 2017

Wed
13 Sep
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2017 Process Validation Statistics Conference
Bethesda, MD USA

Dates: 13 Sep 2017 - 15 Sep 2017

Tue
26 Sep
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2017 Europe Biotechnology Conference
Dublin, Ireland

Dates: 26 Sep 2017 - 27 Sep 2017

Sun
29 Oct
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2017 ISPE Annual Meeting & Expo
San Diego, CA USA

Dates: 29 Oct 2017 - 01 Nov 2017

Thu
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

Mon
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

Mon
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

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

Dates: 14 Jun 2017 - 15 Jun 2017

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

Dates: 19 Jun 2017 - 20 Jun 2017

Mon
10 Jul
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HVAC CGMP Regulations Training Course - T14
Tampa, FL USA
Dates: 10 Jul 2017 - 12 Jul 2017

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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

Sarcoma
A type of cancer that starts in bone or muscle.