2-Day Agenda
Practical ICH Q10 Pharmaceutical Quality System (PQS) Implementation Training
Day 1: ICH Q10 Foundations, Regulatory Expectations & PQS Framework
5 Hours | Build the foundation for effective PQS structure, quality monitoring, and risk-based oversight.
Session 1: Introduction to Pharmaceutical Quality Systems
- Evolution of Pharmaceutical Quality Systems
- Importance of ICH Q10 in modern pharmaceutical manufacturing
- Relationship between ICH Q8, Q9, and Q10
- Lifecycle approach to quality management
- Regulatory expectations from FDA, EMA, MHRA, and PIC/S
Session 2: ICH Q10 Model and PQS Framework
- Key elements of the ICH Q10 Pharmaceutical Quality System
- Building an effective PQS structure
- Quality manual and documentation systems
- Management responsibilities and leadership commitment
- Developing a sustainable quality culture
Session 3: Process Performance & Product Quality Monitoring
- Process monitoring systems
- Product quality review expectations
- Quality metrics and trending
- Risk-based quality oversight
- Data integrity considerations within PQS
Session 4: Quality Risk Management Integration
- Integration of ICH Q9 principles into PQS
- Risk identification and assessment techniques
- Risk-based decision making
- Managing critical quality attributes and process parameters
- Practical risk management examples in manufacturing
Session 5: Interactive Discussion & Q&A
- Common implementation challenges
- Regulatory inspection observations and lessons learned
- Industry case studies and discussion
Day 2: Practical Implementation, CAPA, Inspection Readiness & Continuous Improvement
5 Hours | Apply PQS principles to CAPA, change management, supplier quality, inspection readiness, and improvement systems.
Session 1: CAPA and Investigation Systems
- Effective deviation management systems
- Root cause investigation best practices
- CAPA effectiveness and sustainability
- Preventing repeat failures and recurring deviations
- Regulatory expectations for investigations and CAPA
Session 2: Change Management within PQS
- Establishing an effective change control system
- Managing process, equipment, and procedural changes
- Risk evaluation for proposed changes
- Change implementation and effectiveness verification
- Common change management compliance gaps
Session 3: Supplier Quality Management & Outsourced Activities
- Supplier qualification and oversight
- Managing contract manufacturers and laboratories
- Quality agreements and responsibilities
- Risk-based supplier monitoring
- Inspection focus areas for outsourced operations
Session 4: Inspection Readiness & Continuous Improvement
- Building an inspection-ready quality system
- Preparing for FDA and global regulatory inspections
- Managing audit observations and remediation
- Continuous improvement strategies
- Quality culture and operational excellence initiatives
Session 5: Practical Implementation Workshop & Final Q&A
- Real-world PQS implementation examples
- Common industry challenges and solutions
- Practical action plans for attendees
- Open Q&A session with instructor
Course Overview
An effective Pharmaceutical Quality System (PQS) is the foundation of GMP compliance, FDA inspection readiness, and continuous improvement throughout the pharmaceutical product lifecycle. Based on ICH Q10 Pharmaceutical Quality System guidance, this intensive 2-day virtual training course provides practical guidance on designing, implementing, maintaining, and improving a robust PQS that meets current FDA, EMA, MHRA, and global regulatory expectations.
Participants will gain a comprehensive understanding of the ICH Q10 Pharmaceutical Quality System, ICH Q9(R1) Quality Risk Management, CAPA, Change Management, Supplier Quality Management, Process Performance and Product Quality Monitoring, Management Review, and Inspection Readiness. Through practical examples, regulatory case studies, and implementation strategies, attendees will learn how to strengthen quality systems, improve GMP compliance, enhance operational performance, and build a sustainable culture of quality and continuous improvement across pharmaceutical and biotechnology organizations.
Who Will Benefit
This seminar is designed for professionals involved in implementing, managing, and improving Pharmaceutical Quality Systems, including:
- Quality Assurance (QA) & Quality Control (QC) Professionals
- GMP Compliance & Regulatory Affairs Professionals
- Pharmaceutical Quality System (PQS) Managers
- Manufacturing & Operations Managers
- Validation & Engineering Professionals
- CAPA, Deviation & Investigation Specialists
- Supplier Quality & Internal Auditors
- Continuous Improvement & Operational Excellence Professionals
- Technical Services (MSAT) Professionals
- Pharmaceutical, Biotechnology, and Contract Manufacturing (CMO/CDMO) Professionals
What Our Attendees Say
⭐⭐⭐⭐⭐ Excellent Practical Training
"Excellent course with practical guidance that goes beyond the ICH Q10 guideline. The instructor demonstrated how to build and maintain an effective Pharmaceutical Quality System using real-world examples, making it easy to apply the concepts within our organization."
— Director, Quality Systems | Global Pharmaceutical Company
⭐⭐⭐⭐⭐ Highly Recommended
"One of the most valuable quality management courses I have attended. The sessions on CAPA, Quality Risk Management, Change Management, and Management Review were practical, engaging, and directly applicable to our GMP operations and inspection readiness efforts."
— Senior Manager, Quality Assurance | Biotechnology Company
⭐⭐⭐⭐⭐ Exceeded Expectations
"The instructor combined regulatory expectations with practical implementation strategies that can be used immediately. This course has helped us identify opportunities to strengthen our Pharmaceutical Quality System and improve overall compliance."
— Head of Quality | Pharmaceutical Manufacturer
Know Your Faculty (25+ yrs exp.)
Kelly Thomas Head of Quality Assurance (USA)
A seasoned Quality Assurance, Quality Control, and Regulatory Compliance leader with 25+ years of experience across API, biologics, medical devices, and combination products. Extensive expertise in aseptic and terminally sterilized manufacturing, along with all major dosage forms.
Proven track record of leading facility start-ups and successfully managing global regulatory inspections, including FDA and international agencies. Known for building strong quality systems, supplier management programs, and audit readiness frameworks.
👉 Brings practical, inspection-ready insights to help you strengthen compliance and avoid costly mistakes.
