Concept Papers

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ISPE periodically offers concept papers authored by groups (such as ISPE’s Communities of Practice (COP)) seeking to establish or clarify a concept, and to determine the level of interest in the concept discussed. The outcome may lead to a Guidance Document.

Considerations for a Corporate Data Integrity Program New
By the ISPE GAMP COP
Published: March 2016

Improving Access for Patients with Unmet Medical Needs – Overview and Best Practices for Success
By the ISPE IP COP
Published: June 2014

Validation and Data Integrity in eClinical Platforms
By the ISPE GAMP COP
Published: June 2014

The Application of GAMP® 5 to the Implementation and Operation of a GxP Compliant Clinical System
By the ISPE GAMP COP
Published: September 2013

Controlled Temperature Chamber Mapping
By the ISPE Packaging COP
Published: April 2012

Implementing Knowledge Management in Bioprocesses: A QbD Driven Approach Turning Data into Knowledge in Reference to the CMC A-Mab Case Study
By the ISPE Process Analytical Technology (PAT) COP Data Management Task Team
Published: March 2012

Use of Booklet Labels on Investigational Medicinal Products (IMPs)
By the ISPE Investigational Products (IP) COP Booklet Label Task Team
Published: February 2012

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Design Considerations for WFI Distillation Systems Part 4
Thursday, 26 May 2016 13.05

Direct Access to Quality Manufacturing Experts
Wednesday, 25 May 2016 13.05

Broadening Pharmaceutical Training Footprint in Europe
Tuesday, 24 May 2016 19.05