Lesson series

Advanced 6: Advanced Quality Management System

Quality Management is considered the most important GMP system and as such the functioning of the Quality Management System (QMS) is central during regulatory inspections. A QMS consists of 10 fundamental elements and this course explains the process flows for most these elements.  ICH Q10 now includes a continuous improvement requirement within the quality system and this is covered in the context of change management, quality metrics, auditing and management reviews.
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5 Topics

Across 3 hours of online content

5 Case Studies

Direct from industry

5 Quizzes

Check your knowledge

1 Assessment

Complete the course

1 Q&A Webinar

Live session with a CBE Expert
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Supplementary Learning Materials

Videos, resources, useful reading, links and examples

Who is this course for?

This course is designed for those with an interest in risk management and who want to supercharge their in-depth understanding of risk application in a GMP environment. 

Senior Managers

The skill you need to become a real professional.

Quality

Learn the tools used by the world's top professionals.

Operations

Boost your confidence, master "the field".

Meet your trainers for this course

Our trainers have decades of industry knowledge, technical expertise and practical experience across all aspects of the biopharmaceutical sector. 

Steve Williams

Course Trainer

With over 45 years experience in the Biotechnology, Pharmaceutical and Medical Device industries, Steve provides strategic solutions to regulatory and compliance challenges, along with advanced training courses. He has over 25 years consulting experience in GMPs, Compliance, Auditing, Training and Quality Systems to all international standards.

Maurice Parlane

Course Trainer

Maurice has significant international experience as a subject matter expert and specialist trainer in science and risk based approaches to manufacturing across the biopharmaceutical industry. He is a  professional engineer with over 30 years of experience in technical and consulting roles. 

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