Are your aseptic facility designs and operations aligned with EU GMP Annex 1 expectations and FDA inspection readiness?
This expert-led webinar cuts through the complexity of modern sterile manufacturing compliance by analyzing the Top 10 critical requirements for building compliant sterile facilities—plus detailed case studies of real FDA 483s (2024–2025) that reveal the exact design flaws, operational gaps, and behavioral lapses that inspectors are seeing in the field today.
Learn how leading sterile injectable manufacturers are preventing costly compliance failures, recalls, and regulatory action through proactive facility design, robust environmental monitoring, and superior quality oversight.
KEY TAKEAWAYS
- Top 10 Requirements for Sterile Facility Design – The foundational elements inspectors verify at every audit
- Annex 1 Cleanroom Layout & Airflow Rules – Section-by-section guidance on zoning, pressure differentials, and sealed barriers
- Where Inspectors Look First – Critical inspection focus areas and common red flags
- Real FDA 483 Case Studies – Detailed analysis of BRS Analytical Services and Zydus Lifesciences findings, plus how to avoid them
- Most Common FDA Violations – Top 10 warning letter categories and practical remediation strategies
- Dynamic Airflow Visualization – Why static smoke studies fail and how to validate “first air” under real operating conditions
- Personnel Gowning & Aseptic Technique – How operator practices directly impact sterility assurance
- Environmental Monitoring Best Practices – Correct sensor placement, continuous pressure monitoring, and viable/nonviable sampling strategies
- Validation & Qualification Framework – DQ/IQ/OQ/PQ essentials for equipment, utilities, and aseptic processes
- ✓ Prevention > Remediation – How proactive design, risk assessment, and quality oversight minimize inspection findings and protect your license
WHO SHOULD ATTEND
- Manufacturing Operations Managers – Oversee aseptic facility compliance and operational control
- Quality Assurance & Quality Control Leaders – Responsible for contamination control strategies, environmental monitoring, and regulatory readiness
- Facility and Engineering Teams – Design, build, validate, and maintain sterile manufacturing environments
- Regulatory & Compliance Professionals – Prepare for FDA, EMA, PIC/S, and TGA inspections
- Pharmaceutical, Biotech, and Medical Device Companies – Including CDMO, contract manufacturing, and CRO organizations
- Environmental Monitoring Specialists – Optimize particle counting, viable sampling, and airflow qualification programs
- GMP Training & Quality Consultants – Expand expertise and client advisory services
WHY ATTEND THIS WEBINAR?
- Real inspection readiness – Learn what FDA and EMA inspectors are actually looking for, based on recent 483s and warning letters
- Avoid costly mistakes – Understand the exact design and operational flaws that trigger recalls, regulatory action, and license suspension
- Practical, actionable insights – Case studies with preventive and remediation strategies you can implement immediately
- Regulatory confidence – Walk away with a framework to audit your facility against Annex 1 requirements and FDA guidance
- Peer learning – Connect with quality, operations, and engineering leaders facing similar contamination control challenges
Sign up now at: https://www.golighthouse.com/en/webinars/avoiding-483s-annex-1-cleanroom-design-monitoring-and-inspector-hotspots-dec-17-2025-1am/?wspage=register
