Advancing Pharmaceutical Quality (APQ) Quality Management Maturity Training Course (T74)
Overview
As the industry faces increasing scrutiny from Health Authorities on the assessment of Quality Management Maturity and Continual Improvement, it is more important than ever to have practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS).
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.
In this training, you will be led through the APQ guide series for Quality Management Maturity including how to leverage structured tools using a tested industry best-practice approach to coordinating, conducting, presenting, and reporting out on assessment outcomes. You will learn how the APQ methodology is used to improve the current state of quality and how it can benefit your organization through the Assess, Aspire, Act, Advance Framework.
What You Will Learn
- Background of the APQ Framework
- Overview and Structure of the APQ Framework
- How to conduct the Quantitative Pre- and Post-Assessments
- How to conduct and score a deep dive Assess and Aspire exercise for each element
- How to set up an Act and Advance improvement program
Resources and Activities
- Pre-course materials including an Excel Toolkit for company scorecard assessment
- Interactive Exercises
- Knowledge Checks
- APQ Guide: Cultural Excellence
Course Modules
- APQ Overview
- Model Elements
- Corrective Action and Preventive Action System (CAPA)
- Management Responsibilities & Management Review (MRR)
- Change Management
- Process Performance and Product Quality Monitoring System (PPPQM)
- Cultural Excellence
- Assessment methodology, scoring, and output
Who Should Attend
- This course is intended to be useful to anyone involved in Quality Culture and Quality Management Maturity assessment and Quality measures.
- Professionals with PQS responsibilities including CAPA, Change Management, Management Responsibilities and Management Review, Process Performance and Product Quality Monitoring Systems, and Cultural Excellence, as well as Operational Excellence professionals and regulators.
Additional Course Details
Understanding the complexities of drug shortages has increased with the COVID-19 public health emergency, particularly with supply chain vulnerabilities. It has become apparent that complementary approaches are necessary to address supply and demand driven shortages, including the need to innovatively transition from lagging indicators such as Quality Defect reports, inspection data, and application data to leading approaches driven by QMM ratings.
The APQ program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in their 2019 Drug Shortages report.
Learn and understand how to assess and improve each element of the PQS as described in ICH Q10 using the APQ framework. Walk away from this course with best practices for setting up and conducting an assessment and practical tools to be used to evaluate PQS effectiveness and drive continuous improvement.
APQ Guide Series
The program consists of five Good Practice Guides: one for each of the four elements of an ICH Q10 Pharmaceutical Quality System plus Cultural Excellence, bookended by an optional benchmarking tool developed by University of St. Gallen.
The APQ Guides series proves a set of tool and systematic approaches – the Assess, Aspire, Act, and Advance Framework – for organizations to advance the maturity and effectiveness of these PQS elements.
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