Introduction to this course: 

This course covers essential principles of deviation management, including types of deviations and phases of the process: identifying and reporting deviations and nonconformities, investigation and root cause analysis, risk assessment, CAPAs, effectiveness checks, and periodic reviews.

Who should attend: 

This course is designed for professionals seeking to enhance their skills in deviation management, root-cause analysis, and quality risk management: QA/QC, regulatory affairs, manufacturing and production, compliance, and auditors.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Evaluate and analyze instances of nonconformities and deviations using root-cause analysis methodologies, identifying underlying issues and their impacts on product quality and compliance.

• Formulate and design effective CAPA plans that address identified root causes, ensuring that similar quality events are mitigated in the future.

• Assess the effectiveness of the QMS in handling quality events, applying continuous improvement principles.

What will I gain: 

Participants will gain comprehensive knowledge of deviation management and root-cause analysis, and enhanced ability to apply CAPAs to prevent recurrence of quality events.

Prerequisites: 

Prerequisites for this course include familiarity with QMS and regulatory requirements for handling quality events, and basic problem-solving and analytical skills.

Additional information: 

Course duration: 00:42:40

Course code/version (effective date): L-41/v1.0 (26/04/2023)