ISPE STANDARDS PDF

ISPE STANDARDS PDF

APQ Guide: Change Management (CM) System

APQ Guide: Change Management (CM) System

Full Description What is the current state of your organization's Change Management ..

$309.00 $515.00

APQ Guide: Corrective Action & Preventive Action (CAPA) System

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)

APQ Guide: Management Responsibilities & Review (MRR)

Full Description ICH Q10 sets a clear expectation regarding the role of strong leade..

$309.00 $515.00

Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals

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

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)

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..

$342.00 $570.00

GAMP Good Practice Guide:  A Risk-Based Approach to GxP Process Control

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..

$276.00 $460.00

GAMP Good Practice Guide: A Risk-Based Approach to Calibration Management, Second Edition

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

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)

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)

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

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

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

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

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

GAMP Good Practice Guide: Enabling Innovation

Full Description The drive within life sciences to improve patient safety and produc..

$357.00 $595.00

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