Description
Good Engineering Practices (GEP) are the foundation of designing, operating, and maintaining equipment, utilities, and facilities in regulated environments.
This course provides a practical, structured understanding of engineering principles, qualification requirements, documentation standards, and compliance expectations necessary to support pharmaceutical, biotechnology, food, and chemical manufacturing.
Participants will learn how engineering systems are planned, installed, qualified, commissioned, and maintained following global GEP and GMP standards. The course covers equipment lifecycle management, utilities (HVAC, purified water, compressed air, steam), calibration, preventive maintenance, technical documentation, and engineering change management.
Real case studies and engineering failures are discussed to enhance understanding, highlighting how proper engineering controls directly impact product quality and patient safety.
By the end of this course, participants will be able to:
- Understand the fundamentals of Good Engineering Practices (GEP)
- Apply engineering documentation standards, specifications, and drawings
- Understand equipment lifecycle: URS → Design → FAT/SAT → Commissioning → Qualification asper ISPE.
- Manage utilities and critical systems: HVAC, PW/WFI, CIP/SIP,etc.
- Implement maintenance systems, calibration programs, and spare parts strategies
- Identify engineering risks and apply troubleshooting methods
- Support audits, validation activities, and regulatory inspections
- Strengthen collaboration between Engineering, QA, Validation, and Production
Who Should Attend
This course is ideal for professionals responsible for engineering systems within regulated environments, including:
- Engineering & Maintenance Teams
- Mechanical, Electrical, and Mechatronics Engineers
- QA & Validation Specialists
- HVAC, Utilities & Facility Engineers
- Production Supervisors & Technical Support Personnel
- Project Engineers & System Designers
- Fresh graduates entering engineering roles in pharma and manufacturing
- Anyone responsible for ensuring compliant, reliable, and safe engineering operations
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
· Commissioning& Qualification
· Facility
· HVAC & Clean room Standard
· Pharmaceutical Water Systems
· Equipment
· Automated and computerized systems
Number Of Sessions
6 Sessions