Project Management is tools and techniques supporting project delivery, the life cycle of a typical project in the pharmaceutical industry, and how compliance with pharmaceutical industry regulations is integrated with the project life cycle.
Product
Good Practice Guide: Technology Transfer 3rd Edition
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is…
Product
Good Practice Guide: Operations Management
For the purposes of this Guide, operations are defined as the transformative process within a series…
Product
Good Practice Guide: Project Management for the Pharmaceutical Industry
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good…
Product
Good Practice Guide: Good Engineering Practice 2nd Edition
The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and…
iSpeak Blog
When Speed to Market Counts
Speed to market is a major priority for life sciences companies and this is going to be a featured…
iSpeak Blog
Peer Companies Share Knowledge on Project/Asset Management Interfaced and Shutdown Management in Recent Asset Management Benchmarking Session
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified…
Video
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
Video
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
PE Articles
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
iSpeak Blog
Lean Stability Strategies and Best Practices Discussed during Webinar
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength…
Video
Roundtable Discussion – Lean Stability
Roundtable Discussion – Lean Stability Complimentary Learning Level: Intermediate/Advanced Session…
iSpeak Blog
Implementing Cloud-Based Pharmaceutical Plant Management Software: Data Security Considerations
Cloud-based systems for plant process management (PPM) deliver significant benefits in terms of…
Product
Good Practice Guide: Technology Transfer 3rd Edition
Transfer of manufacturing processes and analytical procedures between facilities or laboratories is…
Product
Good Practice Guide: Operations Management
For the purposes of this Guide, operations are defined as the transformative process within a series…
Product
Good Practice Guide: Project Management for the Pharmaceutical Industry
The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry provides good…
Product
Good Practice Guide: Good Engineering Practice 2nd Edition
The ISPE Good Practice Guide: Good Engineering Practice (Second Edition) defines the practices and…
iSpeak Blog
When Speed to Market Counts
Speed to market is a major priority for life sciences companies and this is going to be a featured…
iSpeak Blog
Peer Companies Share Knowledge on Project/Asset Management Interfaced and Shutdown Management in Recent Asset Management Benchmarking Session
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified…
Video
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects
Project Definition Rating Index (PDRIx) for Manufacturing & Life Sciences Projects Complimentary…
Video
Unlocking the Power of Unified Capital Project Management for Pharma Companies
Unlocking the Power of Unified Capital Project Management for Pharma Companies Complimentary…
PE Articles
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
iSpeak Blog
Lean Stability Strategies and Best Practices Discussed during Webinar
Stability sampling and testing are key to ensuring that products maintain safety, identity, strength…
Guidance Documents
Active Pharmaceutical Ingredients (1)
+Drug Shortages (1)
+Project Management (6)
+Quality Assurance (1)
+Supply Chain Management (1)
+Community Discussions
Community Discussions
Mar 28, 2025
Information Systems
Regulatory
Advanced Manufacturing
Active Pharmaceutical Ingredients
Nov 04, 2024
Information Systems
Management
Pharma 4.0™
Project Management
Webinars
Upcoming
On-Demand
iSpeak Blog Posts
Pharmaceutical Engineering Magazine Articles
ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
Effective and timely management of change throughout the product life cycle enables quality…
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and…
Pandemic Preparedness & Business Continuity
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “ Avian Flu…
Implementation of a Formal Energy-Efficient Design Process
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating…
A Systems-Based Approach to Digital Design & Operation
The Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project is a recently completed…
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
Effective and timely management of change throughout the product life cycle enables quality…
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and…
Pandemic Preparedness & Business Continuity
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “ Avian Flu…
Implementation of a Formal Energy-Efficient Design Process
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating…
A Systems-Based Approach to Digital Design & Operation
The Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project is a recently completed…
Front-End Design of Personalized Medicine Facilities
The commercialization of personalized medicine has ushered in demand for a new type of facility…
ISPE Briefs: New APQ Guide Develop a Robust and Efficient Change Management System
Effective and timely management of change throughout the product life cycle enables quality…
Today’s Pharma and Biotech Projects: A Phased Approach
This article revisits the concept of phased engineering, procurement, and construction (EPC) and…
Pandemic Preparedness & Business Continuity
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “ Avian Flu…
Implementation of a Formal Energy-Efficient Design Process
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating…
Videos
Professional Development Training
Pharma Facilities Project Management Training Course
+White Papers
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
May / June 2024
The commercialization of personalized medicine has ushered in demand for a new type of facility—…
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
