Maintaining Your Risk-Based Cleaning and Disinfectant Programs – Webinar Recording/Transcript
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Cleanliness and sterilization have always been essential. This task is never simple and the COVID-19 pandemic has made it all the more challenging.
Are you working hard to manage the cleanliness of your cleanrooms amid this viral crisis? Follow these tips to make that process more straightforward and successful.
In this presentation, we’ll discuss the newest technologies for keeping your cleanroom sterile and clean. We’ll also tackle the regulatory expectations around this requirement, including those of the FDA, Medicines and Healthcare Products Regulatory Agency (MHRA), Agência Nacional de Vigilância Sanitária (ANVISA), National Administration of Drugs, Foods and Medical Devices (ANMAT), Health Products Regulatory Authority (HPRA), European Medicines Agency (EMA) and Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). You’ll have the chance to learn from the mistakes of past projects through FDA warning letters and discover practices for maintaining your cleanroom.
Cleaning and disinfecting expert Jim Polarine will share tips on how to best design a risk-based program during this global health crisis. He will discuss industry trends, global regulatory expectations and how to maintain a controlled cleanroom. From his experienced perspective, you’ll learn what you need to know to both meet written guidance and create the most sterile cleanroom feasible.
During this presentation, we will cover:
- Regulatory Expectations
- Requirements of FDA, MHRA, ANVISA, ANMAT, HPRA, EMA and ANSM inspectors as they relate to COVID-19
- Lessons learned from FDA warning letters and 483s
- Details in USP 43 <1072>, PDA Technical Report #70, and other industry documents
- New guidance in Draft Annex I
- Keeping cleanrooms controlled to ensure safe, pure and efficacious products
- Disinfecting during the COVID-19 pandemic
- Managing fungal and bacterial spore excursions
- Disinfectant rotation, sterility, application and rinsing
- COVID-19 monitoring, contact tracing and social distancing requirements
Maintaining your cleanroom has become more difficult due COVID-19 but not impossible. With expert guidance, you can manage cleaning, disinfecting and sterilizing with best practices and a risk-based program.
Meet Your Presenter
Jim Polarine is a senior technical service manager at STERIS Corporation, where he’s worked for 20 years. Currently, Polarine’s focus is microbial control in cleanrooms and other critical environments. He is a frequent industry speaker and has published several PDA chapters and articles related to cleaning, disinfection, and contamination control. He is active on the PDA’s COVID-19 Task Force and Microbial Excursions Task Force. He coauthored the PDA’s Technical Report #70 on cleaning and disinfection and teaches industry regulators, as well as pharmaceutical, biotech and medical device professionals.
Who Will Benefit
- Pharmaceutical, biotech and medical device staff
- Hospital compounding pharmacy staff
- Oral solid dose team members
- Validation managers
- Quality control managers
- Lean managers
- Operations managers
- Cleanroom managers
- Regulatory affairs managers
- Production managers
- Quality systems managers
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Aug. 19, 2020