Course Overview:
Designed by industry experts, this advanced certification provides a deep dive into the critical components of global pharmaceutical manufacturing. Whether you are dealing with Injectables, Oral Solid Dosage (OSD) forms, or biologicals, this course equips you with the practical knowledge required to maintain a state of continuous compliance. You will learn the complete lifecycle of facility operations, from engineering and layout optimization to rigorous validation protocols and successful audit management, aligning strictly with EU-GMP and GxP standards.
What You Will Learn (Course Curriculum):
- Module 1: Facility Engineering & Utility Qualification
- Navigating Green Field and Brown Field project setups.
- Reviewing and optimizing facility layouts for EU-GMP compliance.
- Executing qualification protocols for critical utilities (Purified Water, WFI, Pure Steam, Compressed Air, HVAC).
- Module 2: Advanced Quality Management Systems (QMS)
- Developing and implementing a robust QMS.
- Handling critical documentation: Change Controls, Deviations, Incidents, OOS, and OOT investigations.
- Hands-on training for correctly writing, managing, and closing QMS records.
- Module 3: Equipment Qualification & Process Validation
- Mastering the validation lifecycle: FAT, SAT, DQ, IQ, OQ, and PQ .
- Executing Process Validation, Cleaning Validation, and Media Fill protocols.
- Conducting hold time studies for water, media, and cultures.
- Module 4: EU-GMP Audit Readiness & Regulatory Affairs
- In-depth study of EU-GMP Chapters 1 to 9.
- Strategies for facing official EU-GMP inspections and preparing CAPA (Corrective and Preventive Action) plans.
- Understanding Marketing Authorization (MA) Licensing and CTD Module-3 preparation .
Who Should Enroll?
- Production and Plant Managers
- QA/QC Executives and Microbiologists
- Facility Engineers and Validation Specialists
- Regulatory Affairs and Compliance Officers
Course Features:
- Delivery: Tailored modules delivered by experienced EU-GMP professionals.
- Language Options: Comprehensive training available in both English and Vietnamese.
- Certification: AIM Intellix Advanced Certification in Pharmaceutical Manufacturing.
Lessons:
