Pharmaceutical Product Lifecycle Management is the process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal. Lifecycle Management forms the product information backbone for a company and its extended enterprise.
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Lifecycle Management (5)
- Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt
- Guide: Biopharmaceutical Process Development & Manufacturing
- PQLI Guide: Part 1 - Product Realization using QbD: Concepts & Principles
- PQLI Guide: Part 2 - Product Realization using QbD: Illustrative Example
- APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
Manufacturing Operations (1)
Process Analytical Technology (3)
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Related Pharmaceutical Engineering Magazine Articles
Webinars Related to Pharmaceutical Product Lifecycle Management
Concept and Discussion Papers
Process Validation Lifecycle for Packaging Oral Solid Dosage Forms
In August 2017, ISPE published the Discussion Paper “Overview of Packaging Validation for Drug…
Process Validation in Context of Small Molecule DS and DP Continuous Manufacturing Processes
Authors: Carly Evans (Akebia Therapeutics), Katherine Giacoletti, (SynoloStats LLC), Declan Hurley…
Process Validation Lifecycle Implementation for Existing Products
Authors: David Dolgin (PSC Biotech), David Hughes (Sandoz), Matthew McMenamin (GSK), Parab Parkash…
Special Initiative Documents
Videos Related to Pharmaceutical Produce Lifecycle Management
iSpeak Blog Posts
Training Programs Related To [Category]
Asset Information Lifecycle Modelling
The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This ' digital asset ' reflects the value of data that mirrors the physical assets. The genesis of this digital asset (engineering data) is created and collected from various disparate sources. This information is also consumed by a variety of disparate functions. To facilitate the efficient creation, manipulation and consumption of engineering information it is important to define a master data model for the whole asset lifecycle . The identification of the…
Quality Management Systems Training Course
Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.
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.