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.
Related Guidance Documents
Knowledge Management (1)
Lifecycle Management (3)
Process Analytical Technology (4)
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iSpeak Blog Posts Related to PAT & Lifecycle Control Strategy
Related Pharmaceutical Engineering Magazine Articles
Agile, Data-Driven Life Cycle Management for Continuous Manufacturing
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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
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Videos Related to PAT & Lifecycle Control Strategy
Training Programs Related to PAT & Lifecycle Control Strategy
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.
Concept and Discussion Papers
March / April 2024
Navigating the Asia Pacific Pharmaceutical Landscape for Global Impact Cover: The Asia Pacific…
Pharma 4.0 – Towards IT/OT Architectures for Prescriptive Maintenance
Introduction Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers…
Process Events for the Life Science Industry - Information Model Concept on OPC UA for Alarms and Audit Trails
Abstract Plug & play in general describes a piece of equipment that is ready to use upon connecting…
