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.
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…
PE Articles
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
PE Articles
Modular Approaches in ATMP Innovation
Discover how modular manufacturing concepts are transforming the biopharmaceutical industry. Unlike…
iSpeak Blog
Strategic Planning for Measurable Outcomes in Pharmaceutical Manufacturing
In the fast-paced and ever-evolving world of pharmaceutical manufacturing, companies must respond to…
iSpeak Blog
Overcoming Fear of the Engineer-Procure-Construct (EPC) Model to Recognize Project Execution Benefits
In an increasingly complex world, where the reliable delivery of power from point A to point B often…
Video
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
Video
Women in GAMP®
Women in GAMP ® Complimentary Learning Level: Basic/Intermediate Session Length: 1 hour Join us for…
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…
PE Articles
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
PE Articles
Modular Approaches in ATMP Innovation
Discover how modular manufacturing concepts are transforming the biopharmaceutical industry. Unlike…
iSpeak Blog
Strategic Planning for Measurable Outcomes in Pharmaceutical Manufacturing
In the fast-paced and ever-evolving world of pharmaceutical manufacturing, companies must respond to…
iSpeak Blog
Overcoming Fear of the Engineer-Procure-Construct (EPC) Model to Recognize Project Execution Benefits
In an increasingly complex world, where the reliable delivery of power from point A to point B often…
Video
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations Lifecycle
Bridging the Gap: Leveraging Capital Project Data to Enhance the Pharma Manufacturing Operations…
Guidance Documents
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+Drug Shortages (1)
+Project Management (6)
+Quality Assurance (1)
+Supply Chain Management (1)
+Community Discussions
Community Discussions
Apr 16, 2025
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Mar 28, 2025
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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 “ADDoPT—Advanced Digital…
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
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 “ADDoPT—Advanced Digital…
Volunteer Profile: Trish Melton, PhD, Guidance Documents Committee Immediate past Chair
Trish Melton, PhD, has over 30 years of experience in the pharmaceutical industry, working in both…
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…
Videos
Professional Development Training
Good Engineering Practice (GEP) Training Course
+Pharma Facilities Project Management Training Course
+White Papers
May / June 2025
The ATMP Issue: In this issue, we focus on the manufacturing of advanced therapy medicinal products…
March / April 2025
A Skill Management Framework for a Pharma 4.0™ Workforce Feature: Pharma 4.0™ is driving fundamental…
January / February 2025
GAMP® is indispensable for safeguarding the safety, quality, and compliance of pharmaceutical…
