Quality Assurance

Overview The " Legacy Systems" section of the GAMP ® Basic Principles (T45) training course addresses the challenges and regulatory expectations surrounding operational GxP systems that lack sufficient validation or documentation. Participants learn how legacy systems arise from organizational changes to neglected validation and documentation, and why they pose compliance risks. Drawing guidance from PIC/S and EU Annex 11, the module emphasizes the need to demonstrate fitness for intended use, manage GxP risks, and maintain system control. Learners explore how to apply GAMP® 5 lifecycle…

Overview The " Effective and Efficient Compliance" section of the GAMP ® Basic Principles (T45) training course emphasizes strategies for achieving regulatory compliance in a streamlined, risk-based, and resource-conscious manner. Participants explore key efficiency improvements, including leveraging supplier documentation, combining specification deliverables, using automated testing tools, and minimizing unnecessary documentation. The module highlights how risk-based decision-making applies across the system lifecycle from specification and testing to operational change management and system…

Overview The " Operational Phase for GxP Regulated Systems" section of the GAMP ® Basic Principles (T45) training course focuses on the governance, control, and maintenance of computerized systems after deployment. Drawing from GAMP® 5 Second Edition, the module outlines key operational appendices covering areas such as system handover, support services, monitoring, incident management, change control, configuration management, backup and restore, business continuity, and system retirement. Participants learn to tailor operational activities to system risk and complexity, implement robust…

Overview The " Computer Software Assurance (CSA)" section of the GAMP ® Basic Principles (T45) training course introduces the FDA’s evolving guidance on CSA, emphasizing a risk-based, patient-centric, and quality-focused approach to software validation and assurance. Moving away from traditional documentation-heavy practices, CSA encourages critical thinking, defect prevention, and efficient assurance activities tailored to the software’s intended use and risk level. Participants explore key concepts such as high vs. not-high process risk, scripted and unscripted testing methods, and…

Delivery Mode: Webinar An introduction to the ICH Q9(R1): Guidelines on Pharmaceutical Risk Management. This lesson covers the fundamentals for assessing and mitigating risks during drug product lifecycles and incorporates the latest requirements from ICH Q9(R1), which was updated in 2023, and supports and sets the foundation for a safety and quality-centric approach. By integrating with other ICH standards, it sets the foundation for a safety and quality-centric approach. CEUs are provided once you achieve an 80% passing grade and complete the evaluation. The course is self-paced. On average…

The ISPE Advancing Pharmaceutical Quality™ (APQ) Program has been developed by industry representatives, for industry use, to provide a practical framework that organizations can use to assess and advance the state of quality within their organization. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and provides a range of sustainable and practical quality management improvement strategies.

Obtain a 10% Savings by Purchasing All Eleven Courses Overview ISPE is presenting an eleven-part series that will focus on the fundamentals of good manufacturing practices (GMPs). The series provides an overview of the regulations pertaining to GMPs and covers topics such as: manufacturing controls, product distribution, plant hygiene, documentation practices, buildings & facilities, organizational structure, and more. This offering gives users access to all eleven modules of the series and is intended to introduce GMPs for the new pharmaceutical employee or to provide an annual refresher for…

CAPA and Continuous Improvement using Process Performance & Product Quality Monitoring (PPPQMS), are elements of the Pharmaceutical Quality System (PQS), supported by ICH Q10. By practicing effective CAPA and PPPQMS a Pharmaceutical Quality System can realize Quality Management Maturity.

In this course, you will learn the requirements for storing, handling, and distributing finished products to ensure they are stored properly and not contaminated or altered during transport. For a limited time, registration fees are waived for this course. Included in the GMP Refresher Certificate Program The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their learning experience by selecting two out of eleven GMP Fundamentals modules. Learn More and Register Interactive Course: What to Expect CEUs are provided…

In this course, you will learn how to ensure the safety and quality of pharmaceutical products using fundamental principles and best practices. During this course, you will learn about the FDA's pharmaceutical packaging and labeling guidelines. You will gain an understanding of the basics of packaging and labeling operations, including production and inspection processes, documentation, and record-keeping. Included in the GMP Refresher Certificate Program The ISPE Academy’s comprehensive GMP Certificate program includes a mandatory GMP refresher course and allows learners to customize their…