ISPE TRAINING: Quality Management Systems Training
►►► 1 for 1 LIMITED TIME OFFER extended to 8 May!
📅 18-19 Jun 2026
⌚ 9.00am-5.00pm SGT
📍Genting Hotel Jurong, Singapore
⚠️ In-Person
Quality Management Systems: Agile Approach for Product Realization & Lifecycle Management (T57)
Overview
The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. 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. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach.
What You Will Learn
- International regulatory PQS guidelines from EMA, USFDA and PIC/s and related regulatory actions to understand how compliance, science and risk both depend on the QMS/PQS.
- Background, objectives and the business benefits of ICH documents:
- Q10 Pharmaceutical Quality System
- Q9 Quality Risk Management
- Q8 Pharmaceutical Development
- Q11 Development and Manufacture of Drug Substances
- Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (draft)
- The PQS’ role in quality and regulatory phases of the lifecycle including development, technology transfer, manufacture and discontinuation.
Resources and Activities
Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- ISPE PQLI® Guide Series: Part 3, Change Management System as a Key Element of a Pharmaceutical Quality System
- Part 4, Process Performance and Product Quality Monitoring System
Course Modules
- Introduction ICH Q10 background, regulatory, lifecycle & elements
Regulatory & Q10 Background- Breakout Scenario - Warning Letters
- Summary of Q10
- Breakout Scenario - ICH Q10
- Enablers
- Knowledge management and quality risk management
- Management Responsibilities & Outsourced activities
- Breakout Scenario: Management Responsibilities
- Product Performance & Product Quality Monitoring System (PPPQMS)
- Breakout Scenario: Development and manufacturing for API, a new product, a legacy product
- Using the process performance and pharmaceutical quality system to drive continual improvement
- CAPA and Change Management and Change Management and link to QRM
- Breakout Scenarios: Change Management
- Management Review
- Quality Culture Module
- Tools and concepts
Who Should Attend
- Quality Assurance
- Tech Support
- Tech transfer functions
- Operations functions
- Early career (3-5 years within the industry)
- Qualified persons in Europe
- Team Lead/Operator/Technician Staff
- Managers
- Section heads
- Supervisors and CEOs
- President
- Owner or General Manager working in pharmaceutical and biotech manufacturing (not CMO)
- Engineering
- Architecture or construction
- Service provider or consulting
- Equipment or material supplier
Agenda
Day 1
0900 - 1000 ISPE Opening, Course Introduction
1000 - 1030 Group Exercise
1030 - 1045 Coffee Break
1045 - 1200 Section 1 Regulatory & Q10 Background
1200 - 1300 Lunch Break
1300 - 1400 Breakout Session: Warning Letters & Discussion
1400 - 1430 Section 2 Summary ICH Q10
1430 - 1445 Coffee Break
1445 - 1545 Section 3 Management Responsibilities & Outsourced Activities
1545 - 1630 Section 4a Quality Risk Management
1630 - 1700 Breakout Session: QRM Exercise
Day 2
0900 - 0915 Re cap of Day 1, Q&A
0915 - 0945 Section 4b Statistics
0945 - 1045 Section 5a PPPQMS - Prod Understanding & Tools
1045 - 1100 Coffee Break
1100 - 1200 Section 5b PPPQMS - Monitoring, PV & Review
1200 - 1300 Lunch Break
1300 - 1400 Breakout session: PPPQMS exercise and discussion
1400 - 1500 Section 6 CAPA & APQ
1500 - 1515 Coffee Break
1515 - 1615 Section 7 Change Management
1615 - 1700 Breakout session: Change Management
Led by:
Shanshan Liu
Global Process Science & Regulator Director, Fedegari
ISPE Singapore Affiliate, Conference Chair
ISPE International Board of Directors
Shanshan Liu is the current Global Process Science & Regulator Director at Fedegari, responsible for leading strategic advancement of manufacturing systems for emerging and complex modalities and driving engagement with global regulatory authorities. She received her M.Sc. in Biochemical Engineering from the University of Birmingham and brings an international perspective to her work from her experiences across various continents.
Throughout her 20-year career, Shanshan has held various technical roles within consulting firms and major pharmaceutical companies, including Novartis, where she worked within the Global Engineering organization and gained exposure to well-established engineering and quality systems. With a solid technical background, Shanshan expanded her expertise into the Quality, Compliance, and Regulatory domains, assisting pharmaceutical and medical device manufacturers in establishing quality systems, remediating quality and compliance risks, and forming regulatory strategies. Through these projects, Shanshan has developed close collaborations with manufacturers, associations, and international regulators.
Shanshan is passionate about connecting people and technologies in the life science industry, and is devoted to fostering international collaborations. She currently serves on the ISPE International Board, contributing to its global mission and vision. To further share her knowledge, Shanshan is qualified as an ISPE instructor for various modules, spanning GMP to ATMP.
Registration
►►► 1 for 1 LIMITED TIME OFFER extended to 8 May!
Member - US$ 895 / SGD 1,195
Non-ISPE Member - US$ 1,095 / SGD 1,485
Government / Academia / Emerging Economies - US$ 550 / SGD 735