ISO 9001:2015 : Quality Management System for Pharmaceuticals

Master the knowledge and skills to implement and manage a Quality Management System (QMS) in the pharmaceutical industry with our ISO 9001:2015 course. Tailored for this sector, it covers key principles and clauses, ensuring compliance, improvement, and operational excellence. 

Who should enroll?

This course is designed for quality assurance and control professionals, regulatory affairs specialists, and managers overseeing pharmaceutical quality systems. It is also ideal for those aiming to align operations with ISO 9001:2015 standards or seeking to deepen their understanding of Quality Management Systems (QMS) in the pharmaceutical industry.

Topics outlined in the course:

• Overview of ISO 9001:2015 and its relevance to pharmaceuticals.
• Understanding the context of the organization to align QMS with business objectives.
• Leadership and its pivotal role in fostering a quality-focused culture.
• How to Design a Pharmaceutical QMS
• How to Implement ISO 9001:2015 Standards
• How to Maintain and Monitor QMS Effectiveness
• Practical tools to align QMS with regulatory & business objectives

This comprehensive course provides an in-depth exploration of Quality Management Systems for Pharmaceuticals, highlighting the key elements of ISO 9001:2015 in a practical, interactive format. Each session includes real-world examples and assessments to enhance applied learning. Upon completion, participants will earn a globally recognized QMS training certificate, accredited with CPD/CEU credits.

Curriculum:

Introduction

Lesson 1: Structure of the ISO 9001:2015 Standard

Lesson 2: Context of the Organization (Clause 4)

Lesson 3: Leadership (Clause 5)

Lesson 4: Planning (Clause 6)

Lesson 5: Support (Clause 7)

Lesson 6: Operation (Clause 8)

Lesson 7: Performance Evaluation (Clause 9)

Lesson 8: Improvement (Clause 10)

Conclusion

Evaluation