Get ready for an exciting 1-day adventure at the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin, Ireland! This state-of-the-art facility is your gateway to hands-on learning in a dynamic environment that simulates real-life bioprocessing scenarios.
Imagine rolling up your sleeves and diving into demo equipment that mirrors actual pharmaceutical manufacturing conditions. This immersive experience allows you to take your theoretical knowledge and transform it into practical skills, all while having fun! Guided by industry experts, you’ll explore the latest techniques and best practices for developing a top-notch Environmental Monitoring Contamination Control Strategy.
But that’s not all! You’ll also learn how to interpret EM data to supercharge your cleanroom operations. Ever wondered if you could reduce Air Change Rates based on Cleanroom Certification data? Absolutely! We’ll show you how to leverage EM data to make smart, energy-saving decisions that help your company go greener.
Whether you’re new to the field or looking to refresh your skills, this course is designed to empower you with the knowledge and experience needed to excel in Environmental Monitoring GMP. Don’t miss this chance to learn, practice, and connect with fellow professionals in one of the world’s leading bioprocessing training facilities.
National Institute for Bioprocessing Research and Training
NIBRT’s mission is to help the growth and development of the biopharma manufacturing industry by providing cutting edge training and research solutions. The Institute is based on an innovative collaboration between Industry, Government and Academia and opened its world class facility in 2011 in Dublin, Ireland.
The facility was primarily funded by the Government of Ireland through Ireland’s inward investment promotion agency, IDA Ireland, which is responsible for the attraction and development of foreign investment in Ireland. NIBRT offers a training and research experience not previously possible anywhere in the world.
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Jason Kelly brings over 28 years of expertise in Environmental and Particle Monitoring Solutions tailored for the cleanroom industry. With his decades of experience, he has successfully managed and installed numerous monitoring systems across Ireland, Europe, Australia, Asia, and the USA. His commitment to compliance is evident in his designs, which are meticulously crafted to meet cGMP regulations while ensuring that they enhance operational efficiency rather than hinder it.
As Applications Director, Jason is passionate about advancing particle monitoring techniques and data integrity. He has contributed valuable insights on best practices for using particle counters effectively, emphasizing the importance of accurate data for critical process decisions. His work focuses on minimizing sampling errors and optimizing configurations to balance precision with practical feasibility.
Environmental Monitoring Systems for Pharmaceutical, Medical Device, Life Science, Semiconductor, Aerospace, and Military Cleanroom applications. Particle Counter, Environmental Sensors and Air Sampling Systems service and integration as well as technical publications and main contributor to LWS Knowledge Center
Haşim is a prominent figure in the world of cleanroom technologies, serving as the General Manager of Lighthouse Worldwide Solutions EMEA Operations. With deep expertise in cleanroom design, environmental monitoring systems, pharmaceutical manufacturing, and regulatory concerns, Haşim has established himself as a leading international expert in contamination control.
His impressive professional portfolio includes founding the Cleanroom Technologies Society of Turkey (CTS), heading delegates in ISO TC209 for “Cleanrooms and associated controlled environments,” and serving as an expert in various ISO TC209 Working Groups. Currently, he holds the position of secretary general for the International Confederation of Contamination Control Societies (ICCCS), a multi-national community representing over 20 countries’ societies focused on cleanrooms and contamination control.
As a faculty member of the Institute of Environmental Sciences and Technology (IEST) Contamination Control Institute (CCI), Haşim lectures on Cleanroom Classification, Monitoring, Testing, and Certification. His leadership continues to expand, with a planned term as VP of Planning on the IEST Executive Board from 2024-2026.
Haşim maintains active memberships in several prestigious professional organizations, including IEST, CTS, the International Society for Pharmaceutical Engineering (ISPE), and the Parenteral Drug Association (PDA).
The cleanroom world is buzzing with excitement over the game-changing ISO/TR 14644-21:2023! This isn’t just another dry technical document – it’s your ticket to mastering particle sampling techniques and staying ahead of regulatory curves.
Imagine having a crystal-clear roadmap to achieve pinpoint accuracy in your cleanroom data. That’s exactly what this new guidance offers, crafted by industry luminaries like Haşim Solmaz from the ICCCS Technical Committee. It’s not just about having fancy equipment anymore; it’s about wielding it with precision.
Here’s the scoop: even top-of-the-line particle counters can be led astray by subpar sampling methods. ISO/TR 14644-21:2023 is your secret weapon against false data, offering a treasure trove of insights to optimize your techniques and paint a true picture of your cleanroom environment.
But wait, there’s more! Regulators are already using this guidance as their go-to playbook. By joining our “Hands On” training course, you’ll be steps ahead of the game. You’ll learn the art of precise probe positioning, mastering the delicate dance of minimal tubing and bends to ensure your data integrity is rock-solid.
The cherry on top? You’ll walk away with practical tools that’ll make you feel like a contamination control superhero. We’re talking about a ready-to-use SOP and validated calculators that’ll have you validating particle losses across your sampling systems in a mere 20 minutes. It’s like being handed the keys to the cleanroom kingdom!
Don’t let this opportunity slip through your gloved fingers. With industry titans like Haşim Solmaz backing this guidance, you’ll be armed to tackle the latest cleanroom challenges head-on.
Have you ever wondered how the pros really certify a cleanroom? It’s not just about counting particles; it’s about achieving true regulatory excellence. Our comprehensive hands-on demo will show you exactly how it’s done, equipping you with the tools you need to elevate your environmental monitoring to expert levels.
We’ll dive deep into the ISO 14644-1:2015 standards, demonstrating how to seamlessly integrate them into your operational plan. You’ll learn to develop effective SOPs with strategically chosen sampling locations that reflect your unique process conditions. Additionally, we’ll explore how to analyze particle count data from multiple points, transforming this information into valuable insights that can significantly boost your operational performance.
But we don’t stop there. We’ll also cover the crucial aspect of HEPA filter testing following ISO 14644-3. You’ll discover how to use a specialized particle counter to test filter efficiency without the need for oil-based aerosols or bulky equipment. Our live demo will showcase just how easy it is to perform these tests and generate GMP-compliant reports on filter efficiency—just like the pros do.
This isn’t just another dry lecture on standards; we’re bringing ISO 14644-1:2015 and ISO 14644-3 to life, illustrating the incredible power of these standards when applied correctly. By the end of our session, you’ll have a fresh perspective on cleanroom certification and management.
Excited about the future of Environmental Monitoring? Let’s dive into the world of Pharma 4.0 and 5.0! We’ll show you how to revolutionize your EM program with cutting-edge digital technologies and AI-driven solutions.
Imagine robots in your cleanrooms and AI making batch release decisions. Sounds futuristic? It’s closer than you think! This expert-led course will guide you through the essentials of Pharma 4.0 and 5.0, helping you implement the digital technologies of tomorrow in EM all while transitioning from paper-based systems to fully digital solutions. You’ll learn how to integrate EM data with LIMS for real-time decision-making, ensuring data integrity throughout the data lifecycle.
We will also teach you how to set up appropriate alarms based on EU GMP Annex1:2022 guidelines, allowing your alarms to work with you rather than against you. Plus, you’ll discover how to use Statistical Process Control to interpret trend data effectively, enabling you to move towards continuous manufacturing while avoiding nuisance EM alarms.
Ready to become an EM expert for the digital age?
EU GMP Annex 1:2022 is shaking things up, and it’s all about continuous microbial monitoring. Trust me, this is big news for anyone working in Grade A and B cleanrooms!
So, what’s the deal? Well, the new guidelines are putting a huge emphasis on keeping a constant eye on those pesky microbes. It’s not just about doing occasional checks anymore – we’re talking round-the-clock vigilance here. And get this – they want us using both passive and active air sampling. That means settle plates and fancy continuous air monitoring systems working together to give us the full picture.
Now, you might be thinking, “Why all this fuss?” Well, it’s all about catching those contamination risks before they become real problems. It’s like having a superhero team guarding your product quality 24/7!
But here’s the exciting part – we’re offering a course that’ll make you the go-to expert on this new approach. Our “EU GMP Annex 1:2022 Continuous Microbial Monitoring and Pharma 4.0” session is led by an industry guru who’ll show you the ropes of implementing this continuous monitoring effectively.
You’ll learn how to use multiple monitoring tools in harmony, creating a contamination-free fortress around your products. We’re talking cutting-edge tech and practical strategies that’ll have you minimizing risks like a pro, especially when it comes to those tricky operator interventions.
This isn’t just another boring training session – it’s your ticket to becoming a contamination control superhero! You’ll walk away with the know-how to leverage continuous microbial data and create the cleanest, safest manufacturing environment possible.
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