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.
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…
Guidance Documents
Active Pharmaceutical Ingredients (1)
Drug Shortages (1)
Project Management (6)
- Good Practice Guide: Technology Transfer 3rd Edition
- Good Practice Guide: Operations Management
- Good Practice Guide: Project Management for the Pharmaceutical Industry
- Good Practice Guide: Good Engineering Practice 2nd Edition
- Good Practice Guide: Management of Engineering Standards
- The Cultural Excellence Report - Six Key Dimensions
Quality Assurance (1)
Supply Chain Management (1)
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Webinars
iSpeak Blog Posts
Pharmaceutical Engineering Magazine 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…
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…
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…
Pharma Facilities Project Management Training Course
Specifically targeted to the needs of facility projects within the regulated pharmaceutical industry and demonstrates the value inherent in the use of “good practice” project management in the regulated pharmaceutical environment.
White Papers
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…
November / December 2024
Plastic Process Waste in Biopharmaceutical Manufacturing Cover: This article presents a…
