Desription
The Qualification and Validation Workshop delivers a comprehensive, practice-oriented understanding of the qualification and validation lifecycle within the pharmaceutical industry. Participants gain insight into the regulatory expectations, documentation requirements, and risk-based approaches that ensure manufacturing systems, equipment, utilities, and processes perform consistently and produce quality products.
This workshop emphasizes the practical implementation of WHO, GMP Annex 15, and FDA validation principles, guiding participants through each stage from user requirements to performance qualification. Real case studies and validation templates are used to strengthen technical knowledge and industry readiness.
Who Should Attend
This workshop is designed for professionals and Specialists involved in validation and quality activities, including:
- Quality Assurance and Quality Control Professionals
- Validation & Qualification Engineers
- Production and Maintenance Managers
- Engineering & Utility Staff
- Regulatory Compliance Specialists
Key Takeaways
- Flexible Attendance Options – Join in-person at VALOR or virtually through our live interactive platform.
- Recorded Sessions – Enjoy limited access to recordings for one month after course completion for review and reinforcement.
- Repeat for Free – Participants may re-attend inperson any future round of the same course at no additional cost.
- Accredited Certificate – Receive a QR-coded certificate for authenticity verification and professional recognition.
- Comprehensive Resources – Access digital materials, trainer support, and post-course assessments through VALOR’s e-learning platform.
Course Topics
- Validation Life Cycle ( FDA/ ISPE)
- Qualification of HVAC System and Thermal Mapping
- Qualification of Autoclaves and pure steam
- Qualification of Ovens and Tunnels
- Qualification of Compressed air systems.
- Process Validation
- Cleaning Validation
- Validation of Computerized Systems (CSV)
- Qualification of Water System
Number Of Sessions
9 Sessions