Program Overview
This training offers professionals an in-depth understanding of validation processes, from IQ, OQ, PQ to key regulatory compliance guidelines. The program covers essential concepts, real-life challenges, and actionable insights from pharmaceutical, biotech, medical devices, and other regulated industries.. Participants will engage in simulations and case studies to strengthen problem-solving skills, enabling them to efficiently manage validation processes and compliance in their organizations.
Features
- Understand the fundamentals of validation principles and lifecycle approaches.
- Apply risk-based strategies to optimize validation scope and execution.
- Address validation challenges, including deviations and regulatory compliance audits.
- Leverage emerging trends and technologies to enhance validation processes.
Target audiences
- Professionals involved in validation, quality assurance, regulatory compliance, and manufacturing operations.
Curriculum
- 7 Sections
- 30 Lessons
- 1 Day
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- Introduction to Validation5
- 1.1Definition and importance of validation in regulated industries
- 1.2Key validation types: Process, Cleaning, Equipment, and Computer System Validation (CSV)
- 1.3Overview of international regulatory standards (e.g., FDA, EU, ICH, WHO)
- 1.4Lifecycle approach to validation
- 1.5Activity: Quick quiz to assess participants’ baseline understanding
- Validation Master Plan (VMP)5
- Key Validation Documents4
- Practical Considerations in Validation Execution4
- 4.1Challenges in validation execution (e.g., deviations, data integrity)
- 4.2Handling validation deviations and CAPA (Corrective and Preventive Action)
- 4.3Tools and technologies in validation management
- 4.4Simulation: Perform a mock validation activity, including deviation handling and corrective action planning
- Risk-Based Validation Approach4
- Regulatory Compliance and Validation Audits4
- Emerging Trends and Innovations in Validation4
Instructor
