Master deviation management, CAPA, change management, and risk assessment with our comprehensive Quality Management Systems #1 certification. Learn to identify, investigate, and resolve deviations, implement corrective actions, manage changes effectively, and analyze risks within a quality risk management framework. Gain practical skills for continuous improvement and compliance with references from guidelines and standards like ICH Q9, ISO 9001, ISO 31000, ISO 13485, and ISO 14971.

Certification Syllabus:

Course 1: Introduction to Deviation Management and Root-cause Analysis

Deviation management basics: Identify and analyze the causes of quality events— nonconformities, deviations, and failures to apply CAPAs.

Course 2: Introduction to CAPA

Explore how to eliminate nonconformities and deviations by focusing on CAPA to prevent recurrence.

Course 3: Introduction to Change Management

Find out the basics of effective change management in life sciences, covering processes, responsibilities, and key concepts for implementing change management.

Course 4: Introduction to Quality Risk Management

Find out fundamental concepts of Quality Risk Management (QRM), providing practical tools to tailor and optimize risk processes.

Additional Information:

• Who Should Attend: This certification is recommended 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.

• Certification Duration: Approximately 5 hours

• Skill Level: Beginner - Intermediate

• Final Assessment: Yes (4 quizzes)

• Certification Associated: Yes