Quality by Design

High-level overview of quality event management principles and practices. Part 3 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous Quality: Miscellaneous is the third and final course in ISPE’s comprehensive three‑part Quality Training Series...
Quality Control Analytical Lab Testing Fundamentals provides a foundational introduction to the essential laboratory practices that underpin Quality Control (QC) operations in pharmaceutical and biopharmaceutical environments. Designed for those new to QC testing or seeking to strengthen their...
High-level overview of quality event management principles and practices. Part 2 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous This course provides a high-level overview of essential quality documentation practices and SOPs. Rather than focusing...
High-level overview of quality event management principles and practices. Part 1 of the ISPE Quality Training Series Quality: Events Quality: Documentation Quality: Miscellaneous This course offers a high-level summary of quality event topics as an addition to the Quality Events SOP Guidance...
This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach....
Through group exercises, this course on Quality by Design will delve into implementation and operation of an effective and efficient control strategy in manufacturing, which is a key element of process performance and product quality monitoring and continual improvement.
This training course is relevant to individuals working throughout the pharmaceutical product lifecycle in development, manufacturing, quality, and many other roles involved in validation of products and processes. It will help you integrate and link the science and risk-based lifecycle approach for....
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....