Knowledge management efficiently handles information and resources within a commercial organization. The purpose of knowledge management is to share perspectives, ideas, experiences, and information; to ensure the information is available in the right place at the right time to enable informed decisions and to improve efficiency by reducing the need to rediscover knowledge. Knowledge management consists of three areas: accumulating, storing, and sharing knowledge.
Product
GAMP RDI Good Practice Guide: Data Integrity by Design
Published: October 2020 Pages: 176 Table of Contents Special Pricing for Emerging Economies Data…
Product
Good Practice Guide: Knowledge Management in Pharmaceutical Industry
ICH Q10 outlines three objectives: achieve product realization, establish and maintain a state of…
PE Articles
ISPE 2022 Member of the Year: Martin Lipa - An Advocate for Knowledge Management
When nominating Martin (Marty) Lipa, Executive Director, Knowledge Management, Merck & Co. Inc., for…
iSpeak Blog
Advancing Pharmaceutical Quality Cultural Excellence
Cultural Excellence is the expressed and implied ways in which an organization operates. Excellence…
iSpeak Blog
ISPE Advancing Pharmaceutical Quality Program Complete
ISPE is pleased to announce the complete Advancing Pharmaceutical Quality Program (APQ) Program is…
Product
APQ Guide: Cultural Excellence
Cultural excellence is the expressed and implied ways in which an organization operates. Excellence…
Product
APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of…
Video
Advancing Pharmaceutical Quality, Change Management
Complimentary Learning Level: Intermediate Session Length: 1.5 hour The ISPE Advancing…
PE Articles
Webinar: Knowledge Management Insights and More
On 26 January 2022, representatives of the author team for the ISPE Good Practice Guide: Knowledge…
PE Articles
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and…
PE Articles
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation…
PE Articles
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed…
Guidance Documents
Data Integrity (1)
Knowledge Management (7)
- GAMP RDI Good Practice Guide: Data Integrity by Design
- Good Practice Guide: Knowledge Management in Pharmaceutical Industry
- APQ Guide: Cultural Excellence
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
- APQ Guide: Change Management (CM) System
- APQ Guide: Management Responsibilities & Review (MRR)
- APQ Guide: Corrective Action & Preventive Action (CAPA) System
Lifecycle Management (1)
Process Analytical Technology (1)
Community Discussions
Community Discussions
Jan 17, 2025
Data Integrity
Jan 17, 2025
Good Manufacturing Practice
Sustainable Facilities, HVAC, & Controlled Environments
Jan 03, 2025
Dec 20, 2024
Dec 19, 2024
GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
ISPE 2022 Member of the Year: Martin Lipa - An Advocate for Knowledge Management
When nominating Martin (Marty) Lipa, Executive Director, Knowledge Management, Merck & Co. Inc., for…
Webinar: Knowledge Management Insights and More
On 26 January 2022, representatives of the author team for the ISPE Good Practice Guide: Knowledge…
Knowledge Centers Improve Knowledge Capture and Sharing
As the industry experiences significant changes to the way we do business, knowledge capture and…
Effective Knowledge Management in Mergers and Acquisitions
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation…
From Data to Knowledge Management: What to Consider
Although data and knowledge are both stand-alone disciplines that need to be systematically managed…
Integrating Knowledge Management and Quality Risk Management
ISPE held an Expert Xchange on 18 January 2022 entitled “Risk-Based Decision Making: Advancing the…
Videos
Professional Development Training
Good Engineering Practice (GEP) Training Course
This course considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces with GxP. The scope of GEP covers the complete lifecycle of engineering projects and engineered systems from conceptual design to retirement. GEP provides a foundation required across the pharmaceutical industry that other areas, such as GxP build upon. This course, based on ISPE Good Practice Guide: Good Engineering Practice (Second Edition) also defines and clarifies GEP as an enabling process for Quality Risk Management…
ICH Q7: API Guidelines
The ICH Q7 guideline ensures consistent quality and safety in the production of Active Pharmaceutical Ingredients (APIs) by defining globally recognized Good Manufacturing Practices (GMP) for all stages of API manufacturing.
ICH Q8: QbD in Manufacturing
The ICH Q8 guideline ensures a systematic approach to pharmaceutical development by defining globally recognized Quality by Design (QbD) principles to enhance product quality throughout all stages of development.
ICH Q10: Pharmaceutical Quality System (PQS)
The Pharmaceutical Quality System (PQS), as defined by ICH Q10, ensures product quality and continuous improvement throughout the lifecycle of pharmaceutical products. Overview This fundamental online course introduces the Pharmaceutical Quality System (PQS), which is a framework that ensures product quality meets established standards throughout the lifecycle of pharmaceutical products. It aims for suitable process performance by implementing robust controls for drug development and manufacturing, including quality assurance, risk management, and regulatory compliance. The system identifies…
A GAMP® Guide to Computerized Systems Compliance
Fundamental Principles of Compliance for Computerized Systems: Implementing the GAMP® 5 Guide This fundamental online course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP ® guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. Course Modules…
White Papers
January / February 2025
The landscape of clinical trials has been transformed in a post-pandemic world. The first edition of…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
September / October 2024
PIC/S in Latin America: Harmonization of cGMP Procedures Cover: This article offers an overview of…
