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.
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.
Speaker
Kelly ThomasWho Should Attend
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
