Process Analytical Technology (PAT) and lifecycle control strategy are umbrella terms covering a range of essential components for other innovative initiatives, such as quality by design, real-time release, and continuous manufacturing.
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Digital Transformation at the 2023 Annual Meeting & Expo
Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it…
ISPE Process Analytical Technology & Lifecycle Control Strategy Townhall
Complimentary Learning Level: Basic/Intermediate/Advanced Session Length: 1 hour The ISPE Process…
APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Acing an Audit: What to Do Before, During, and after an Inspection
Acing an Audit: What to Do Before, During, and after an Inspection Learning Level: Basic Session…
PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
Published: November 2011 Pages: 232 Table of Contents Special Pricing for Emerging Economies Product…
PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
Published: November 2011 Pages: 188 Table of Contents Special Pricing for Emerging Economies Product…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Digital Transformation at the 2023 Annual Meeting & Expo
Digital Transformation (DT) is impacting every aspect of our personal and professional lives, so it…
ISPE Process Analytical Technology & Lifecycle Control Strategy Townhall
Complimentary Learning Level: Basic/Intermediate/Advanced Session Length: 1 hour The ISPE Process…
APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
The Process Performance and Product Quality Monitoring System (PPPQMS) is a fundamental element of…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes
Using Simulations to Accelerate Pharmaceutical Manufacturing Processes Extended Learning Learning…
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma
Implementing Digital Transformation Using ISPE Guidance Documents - Introduction of PAT to Pharma…
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
This Discussion Paper discusses considerations for process validation (PV) activities with a…
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration
Agile Pharma Manufacturing With Real-Time Scheduling & MES Integration Complimentary Learning Level…
Acing an Audit: What to Do Before, During, and after an Inspection
Acing an Audit: What to Do Before, During, and after an Inspection Learning Level: Basic Session…
Guidance Documents
Knowledge Management (1)
+Lifecycle Management (3)
+Pharma 4.0™ (1)
+Process Analytical Technology (4)
+Quality by Design (2)
+Community Discussions
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Mar 28, 2025
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Mar 14, 2025
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Pharmaceutical Engineering Magazine Articles
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Analyzing System Performance through Process Instrumentation Data
What if the reliability of a system could be improved by accessing the standard data provided with…
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Analyzing System Performance through Process Instrumentation Data
What if the reliability of a system could be improved by accessing the standard data provided with…
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Communities of Practice Profiles: Meet the PAT-LCS CoP
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each…
Analyzing System Performance through Process Instrumentation Data
What if the reliability of a system could be improved by accessing the standard data provided with…
Quality & Regulatory Solutions for PAT in Continuous Manufacturing
Process analytical technology (PAT) is perceived as the main enabler for a robust control strategy…
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification…
Videos
Professional Development Training
Quality Risk Management (QRM) Workshop Training Course
+Implementing Process Analytical Technology Training Course
+GAMP® 5 GxP Process Control Training Course
+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…
