Risk Approach on Validation

DESCRIPTION

The Risk Approach on Validation training course is designed to provide participants with a comprehensive understanding of risk-based validation strategies and techniques. The course will cover the principles, methodologies, and best practices for incorporating risk management principles into the validation process. Participants will learn how to identify, assess, and mitigate risks associated with validation activities to ensure compliance with regulatory requirements and industry standards.

OBJECTIVES

By the end of this training course, participants should be able to:

1. Understand the fundamentals of risk management in the context of validation.
2. Identify and classify risks associated with validation activities.
3. Apply risk assessment techniques to prioritize validation activities.
4. Develop risk mitigation strategies and action plans.
5. Integrate risk management principles into the validation process.
6. Comply with regulatory requirements and industry standards related to validation and risk management.

COURSE OUTLINE

1. Introduction to Risk-Based Validation

• Overview of risk management principles
• Importance of risk-based validation
• Regulatory requirements and guidelines for risk-based validation

2. Risk Identification and Classification

• Common risks associated with validation activities
• Risk identification techniques
• Risk classification and severity assessment

3. Risk Assessment Techniques

• Probability and impact analysis
• Risk matrix and risk scoring
• Prioritizing validation activities based on risk assessment

4. Risk Mitigation Strategies

• Risk mitigation options and strategies
• Developing risk mitigation action plans
• Monitoring and controlling risks during validation

5. Integration of Risk Management in Validation

• Risk-based validation lifecycle
• Incorporating risk management principles into validation protocols
• Documentation and reporting requirements

6. Compliance and Audit Considerations

• Regulatory expectations for risk-based validation
• Auditing risk-based validation activities
• Lessons learned and continuous improvement

TRAINING METHOD

Presentation

Discussion

Case Study

Evaluation

FACILITIES

Training Kit

Handout

Certificate

Lunch + 2x Coffee Break

Souvenir

Pick Up Participant (Jogja only)

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