Outsourcing Environmental Monitoring Webinar: Annex 1 Compliance and Risk Management
Join industry leaders from Cormica for an insightful and practical webinar dedicated to the evolving landscape of microbiological environmental monitoring (EVM). This session focuses on the implications of Annex 1 compliance, effective outsourcing strategies, and risk-based approaches to contamination control.
Designed for professionals across the pharmaceutical, biotechnology, and contract manufacturing sectors, this session offers valuable insights to enhance your EM program’s effectiveness and ensure audit readiness.
What You’ll Learn:
With increasing regulatory scrutiny and operational demands, maintaining a compliant and efficient EM program is more critical than ever. This webinar will explore:
- Annex 1 Requirements: Understanding the latest expectations and their practical impact
- GPT Testing and Transport Validation: Ensuring sample integrity throughout the process
- Contamination Control Strategies: Building robust, proactive systems
- EM Testing Best Practices: Implementing methods that align with current regulatory expectations
- Risk Assessments and EMPQ: Strengthening your qualification and mitigation processes
- Data Trending and Use of Sherpa: Leveraging digital tools to enhance insight and oversight
- Common Audit Findings: How to prevent non-conformities and strengthen compliance
- The Value of Trusted Outsourcing: Partnering with expert contract labs to improve performance and flexibility
Why Watch?
In an era of heightened regulatory expectations, staying compliant with the revised EU GMP Annex 1 is a priority for pharmaceutical and biopharmaceutical manufacturers. This webinar offers an essential opportunity to explore the latest developments in environmental monitoring, understand Annex 1’s practical implications, and refine your contamination control strategies. Whether you’re managing cleanroom facilities, preparing for inspections, or considering outsourcing, this session delivers actionable insights to elevate your EM program.
You will hear from Cormica’s subject matter experts on how to implement effective EM practices, avoid common audit findings, and use digital tools like Sherpa to trend data for proactive decision-making. Attendees will also benefit from a live Q&A session, where real-world challenges and solutions will be discussed in detail.
Cormica’s mission is to improve patients’ lives by providing comprehensive testing services, enabling clients to launch and release their products safely and rapidly across the world.
Environmental Monitoring is a cornerstone of contamination control and product safety. Through Cormica’s expertise, gained from over 60 years of microbiological excellence at Wickham Micro and advanced innovation from Focus Laboratories, we support manufacturers in achieving Annex 1 compliance. Our team provides practical guidance, customised testing strategies, and expert support to ensure your facility maintains the highest microbiological standards.
With Cormica as your partner, you can confidently outsource your EM needs to a trusted contract laboratory. Whether you’re scaling production, addressing new regulatory demands, or establishing a new cleanroom facility, contact us to discuss how we can support your environmental monitoring program at sales@cormica.com
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Authors:
Theodora Wentworth
Lead Senior Scientist - Environmental Monitoring
Wickham Micro
With years of experience in pharmaceutical microbiology, Theodora Wentworth leads the Environmental Monitoring department at Wickham Micro. She specialises in GMP compliance, contamination control strategies, and method development for sterile manufacturing environments. Thea’s combines deep technical knowledge with hands-on experience to guide clients through complex regulatory landscapes, particularly Annex 1. Her leadership in microbial risk assessment and testing protocols makes her a trusted voice in the field.
Paul Lutz
Director of Environmental Monitoring
Focus Laboratories
Paul Lutz is a seasoned validation and regulatory expert with a decade of experience in pharmaceutical quality and compliance. As Director of Environmental Monitoring at Focus Labs, he has led large-scale EM programs, managed complex EMPQ implementations, and advised companies globally on best practices for microbial control. Paul’s practical insight into trending, risk management, and regulatory audits positions him as a leading authority in the contract lab space.