Description
Sterile manufacturing is one of the most critical and highly regulated areas in the pharmaceutical, and medical device industries.
This course provides an in-depth, practical understanding of sterile product manufacturing, focusing on the systems, controls, and quality requirements necessary to ensure aseptic integrity and patient safety.
Participants will learn the full workflow of sterile production, including cleanroom design, gowning, sterilization technologies, environmental monitoring, contamination control strategy, aseptic techniques, media fills, utilities, equipment practices, and Annex 1 expectations.
The program uses real industrial case studies, regulatory guidelines, and hands-on examples to help trainees understand how sterile systems must operate according to EU GMP Annex 1 (2022), FDA guidance, and international sterile manufacturing standards.
By the end of this course, participants will be able to:
- Understand the fundamentals of sterile & aseptic manufacturing environments
- Apply contamination control strategies and risk-based decision-making
- Interpret cleanroom classifications, airflows, pressure regimes & HVAC requirements
- Implement proper gowning, personnel practices, and environmental monitoring
- Understand sterilization methods: SIP, autoclaves, dry heat, filter sterilization, etc.
- Evaluate aseptic processing, media fill qualification & integrity tests
- Identify common sources of microbial, particulate, and pyrogen contamination
- Strengthen audit readiness for sterile production inspections
Who Should Attend
- This course is ideal for professionals working in sterile product manufacturing and regulated environments, including:
- QA/QC Specialists & Microbiologists
- Production & Aseptic Operations Personnel
- Validation & Qualification Engineers
- Sterilization, HVAC & Utilities Engineers
- R&D and Formulation Scientists
- Regulatory & Compliance Officers
- Anyone involved in manufacturing injectables, ophthalmic products, biotech products, or any aseptically processed dosage forms
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
- Infrastructure & Facility Design
- Sterile Processes and Equipment
- Sterile Formulation
- Aseptic Assurance
- Contamination Control Strategy ccs
Number Of Sessions
6 Sessions