Dublin, Aug. 17, 2026 (GLOBE NEWSWIRE) -- The "2 Day Virtual Seminar - Practical ICH Q10 Pharmaceutical Quality System (PQS): Implementation for FDA Compliance & Inspection Readiness (Aug 26th - Aug 27th, 2026)" has been added to ResearchAndMarkets.com's offering.
ICH Q10 Pharmaceutical Quality System: 2-Day Virtual Training Course
An effective Pharmaceutical Quality System (PQS) is essential for maintaining Good Manufacturing Practice (GMP) compliance, supporting FDA inspection readiness, managing product quality, and driving continuous improvement throughout the pharmaceutical product lifecycle. This intensive two-day virtual training course provides practical guidance for designing, implementing, maintaining, and continually improving a robust PQS aligned with ICH Q10 Pharmaceutical Quality System guidance.
Developed for professionals across the pharmaceutical and biotechnology industries, the course addresses current quality and regulatory expectations established by the FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and other global regulatory authorities. Participants will explore how an integrated pharmaceutical quality system can strengthen governance, improve operational performance, reduce compliance risk, and support consistent product quality from development and technology transfer through commercial manufacturing and product discontinuation.
The training examines the principal elements of ICH Q10 and their relationship with GMP requirements and quality risk management. Key topics include ICH Q9(R1) Quality Risk Management, Corrective and Preventive Action (CAPA), Change Management, Supplier Quality Management, Process Performance and Product Quality Monitoring, Management Review, knowledge management, and continual improvement. The program also considers the importance of leadership engagement, clear process ownership, effective quality metrics, and cross-functional accountability.
Participants will learn how to apply risk-based approaches when evaluating quality issues, managing changes, overseeing suppliers, and prioritizing improvement initiatives. The course will highlight methods for developing effective CAPA systems, identifying recurring quality trends, assessing process performance, and using product quality data to support timely and evidence-based decisions. Attention will also be given to management review processes that enable senior leadership to evaluate quality system effectiveness, resource requirements, emerging risks, and improvement opportunities.
Inspection readiness is integrated throughout the course, with emphasis on maintaining a state of control rather than preparing only when an inspection is announced. Regulatory case studies and practical examples will demonstrate how health authorities assess PQS effectiveness, data integrity, quality oversight, investigation quality, CAPA sustainability, change control, supplier governance, and management responsibility. Participants will gain insight into common compliance weaknesses and strategies for addressing quality system gaps before they result in inspection observations or enforcement action.
Through implementation-focused instruction, attendees will be equipped to evaluate existing pharmaceutical quality systems, identify areas requiring improvement, and establish sustainable processes aligned with organizational objectives and regulatory requirements. The course will also demonstrate how quality risk management, performance monitoring, and management oversight can be integrated to improve decision-making and enhance lifecycle management.
Upon completion, participants will have a stronger understanding of how to build and sustain an ICH Q10-compliant Pharmaceutical Quality System that supports global GMP compliance, regulatory inspection readiness, reliable manufacturing operations, and continuous improvement. The training is suitable for quality assurance, quality control, regulatory affairs, manufacturing, validation, engineering, supply chain, technical operations, and senior management professionals responsible for pharmaceutical quality system performance and oversight.Who 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
Speaker
Kelly Thomas
For more information about this training visit https://www.researchandmarkets.com/r/vbzj1v
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