Fundamentals Series

The Fundamentals of Quality Management Systems – Pharma

The key to ensuring consistent product quality and patient safety is the development of a robust Quality Management System (QMS).  This course equips you with the knowledge to navigate regulations, develop a quality manual, and implement key programs in order to build a QMS that delivers high quality products.

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CEU Credits: 0.1
Course Code: ELM-743
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 07/19/2024

Curriculum for this course

What is QMS and Why is It Important for the Pharmaceutical Industry?
QMS Regulatory Requirements
Benefits of QMS Implementation
Document Control
Records Management and Reconciliation
Developing and Documenting Processes
SOP & WI Development Team
Training and LMS
Initiating Training and Audit/Inspection Support
Deviations and Nonconformities
CAPA
Documenting Change Control
Type of Changes to Document
Risk Management
Risk Registry
Internal Audits
Supplier Quality Management
SQM Inspections
Complaints
Rooted in Quality: Your QMS for Success
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Author

peter.alcocer@veeva.com

Director of eLearning Compliance

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