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.
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…
Guidance Documents
Knowledge Management (1)
Lifecycle Management (3)
Process Analytical Technology (4)
Community Discussions
Community Discussions
Sep 18, 2024
Knowledge Management
Process Analytical Technology
Aug 13, 2024
Quality
Advanced Manufacturing
Manufacturing Operations
Webinars
Pharmaceutical Engineering Magazine Articles
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…
Videos
Professional Development Training
Quality Risk Management (QRM) Workshop Training Course
This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.
Implementing Process Analytical Technology Training Course
This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance.
GAMP® 5 GxP Process Control Training Course
This highly interactive classroom course describes how the GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Process Control Systems, and GAMP RDI Good Practice Guide: Data Integrity - Manufacturing Records may be applied to achieve process control systems that are fit for intended use, incorporate data integrity and meet current regulatory requirements.
White Papers
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…
July / August 2024
The explosive growth of advanced therapy medicinal products (ATMPs), particularly cellular…
