ISPE GAMP Guide:  Records and Data Integrity

Upcoming Events and Training

08 May
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2017 ISPE Pharmaceutical Serialization Workshops
Philadelphia, PA USA

Dates: 08 May 2017 - 09 May 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 Sep
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2017 Process Validation Conference
Bethesda, MD USA

Dates: 12 Sep 2017 - 14 Sep 2017

13 Sep
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2017 Process Validation Statistics Conference
Bethesda, MD USA

Dates: 13 Sep 2017 - 15 Sep 2017

26 Sep
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2017 Europe Biotechnology Conference
Dublin, Ireland

Dates: 26 Sep 2017 - 27 Sep 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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Division of Medical Imaging and Hematology Products (CDER)