ISPE STANDARDS PDF

APQ Guide: Change Management (CM) System
Full Description What is the current state of your organization's Change Management ..
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APQ Guide: Corrective Action & Preventive Action (CAPA) System
Full Description What is the current state of your organization's Corrective Action ..
$309.00 $515.00
APQ Guide: Management Responsibilities & Review (MRR)
Full Description ICH Q10 sets a clear expectation regarding the role of strong leade..
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Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals
Full Description Clinical Material (CM) supply chain management is an ever-expanding..
$276.00 $460.00
Draft publication Good Practice Guide: Enabling Innovation
Product Details Published: 01/01/2021..
$140.00 $233.00
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (German Version)
Full Description Please note: This is the German version of GAMP 5. A version of t..
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GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control
Full Description This GAMP® Good Practice Guide: A Risk-Based Approach to GxP Proces..
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GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition
Full Description The GAMP Good Practice Guide: A Risk-Based Approach to Calibration ..
$276.00 $460.00
GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures
Full Description The appropriate management of electronic records and signatures is ..
$276.00 $460.00
GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)
Full Description The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Co..
$276.00 $460.00
GAMP Good Practice Guide: A Risk-Based Approach to Testing of GxP Systems (Second Edition)
Full Description This Guide helps the reader to maximize testing efficiency without ..
$276.00 $460.00
GAMP Good Practice Guide: Calibration Management
Full Description The GAMP Good Practice Guide: Calibration Management is the first i..
$137.00 $228.00
GAMP Good Practice Guide: Data Integrity - Manufacturing Records
Full Description Manufacturing systems, with their link to the physical process, hav..
$225.00 $375.00
GAMP Good Practice Guide: Data Integrity by Design
Full Description This Guide is intended to encourage organizations to adopt a risk-b..
$225.00 $375.00
GAMP Good Practice Guide: Electronic Data Archiving
Full Description This Guide provides a rational and scaleable approach to electronic..
$276.00 $460.00
GAMP Good Practice Guide: Enabling Innovation
Full Description The drive within life sciences to improve patient safety and produc..
$357.00 $595.00