Want to simplify your FDA & MDR biocompatibility strategy? Navigating regulatory requirements can be overwhelming, but getting it right is crucial to avoid costly delays. Join our free expert webinar Wednesday next week at 15:00 GMT, where we’ll break down: ? Key differences between FDA & MDR biocompatibility requirements ? How device classification impacts testing & submissions ? Best practices for a smooth approval process ? Live Q&A – Get your questions answered ??? Featuring Elena Henderson, Principal Consultant at Cormica, with extensive experience in ISO 10993 evaluations & global regulatory submissions. Register now: https://lnkd.in/egetpTGF #MedicalDevices #RegulatoryCompliance #Biocompatibility #FDA #MDR #Webinar #Cormica
FOCUS - A Cormica Lab
生物技术
Bethlehem,Pennsylvania 448 位关注者
GMP, GLP and ISO 17025 Pharmaceutical, Medical Device & Combination Product Testing.
关于我们
That rare laboratory with a FOCUS on technical competency, regulatory compliance, and customer service.
- 网站
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https://FOCUS-lab.com
FOCUS - A Cormica Lab的外部链接
- 所属行业
- 生物技术
- 规模
- 11-50 人
- 总部
- Bethlehem,Pennsylvania
- 类型
- 自有
- 创立
- 1996
- 领域
- Regulatory Compliance、Customer Service、Technical Competency、Compounding Pharmacies、Pharmaceutical 、Biotech、Medical Device Manufacturers、Cosmetic Manufacturers、Contract Testing、cGMP Compliant、Environmental Monitoring、Cleaning Validations、Water Testing、Pharmaceutical Microbiology、503b、USP <71>、Endotoxin Testing、Sterility Testing、USP <85>、Cytotoxicity Testing、USP <87>、USP <61>、Nonsterile Product Microbial Enumeration、USP <62>、USP <51>、Antimicrobial Preservatives Effectiveness、Rapid Microbiology、Genetic Identification 和FDA Registered
地点
FOCUS - A Cormica Lab员工
动态
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FOCUS Laboratories is hosting Back to Basics: Fundamentals of Aseptic Technique. Make sure to attend it on November 20.
Join Us for an Essential Webinar: Back to Basics - Fundamentals of Aseptic Technique Wednesday, November 20 ? 12 PM - 1:15 PM Aseptic technique is a cornerstone in the manufacture of sterile drugs and devices and plays a crucial role in nonsterile product manufacturing and microbiology labs. Understanding aseptic technique goes beyond knowledge—it's about mastering the physical skills vital for maintaining product integrity and safety. In our upcoming webinar, "Back to Basics: Fundamentals of Aseptic Technique," we will delve into the key principles and practices that form the foundation of aseptic processes. This session is perfect for those new to aseptic technique or anyone needing a refresher on the essentials. Key Highlights: - The significance of aseptic technique for manufacturing success - Role of hygiene and personal protective equipment - Understanding air flow and the effects of our interactions - Planning, setup, and process flow strategies - Recognizing common pitfalls and their implications - Methods to evaluate effective aseptic technique Key Takeaways: - Gain a comprehensive overview of aseptic technique fundamentals - Access a graded quiz for training record validation Equip yourself with the knowledge and skills to ensure manufacturing excellence. Register now and embrace the rigor of aseptic technique! ???https://lnkd.in/ejBe3Q_n #AsepticTechnique #PharmaceuticalManufacturing #Webinar #ContinuingEducation #ManufacturingExcellence
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Join Us for an Essential Webinar: Back to Basics - Fundamentals of Aseptic Technique Wednesday, November 20 ? 12 PM - 1:15 PM Aseptic technique is a cornerstone in the manufacture of sterile drugs and devices and plays a crucial role in nonsterile product manufacturing and microbiology labs. Understanding aseptic technique goes beyond knowledge—it's about mastering the physical skills vital for maintaining product integrity and safety. In our upcoming webinar, "Back to Basics: Fundamentals of Aseptic Technique," we will delve into the key principles and practices that form the foundation of aseptic processes. This session is perfect for those new to aseptic technique or anyone needing a refresher on the essentials. Key Highlights: - The significance of aseptic technique for manufacturing success - Role of hygiene and personal protective equipment - Understanding air flow and the effects of our interactions - Planning, setup, and process flow strategies - Recognizing common pitfalls and their implications - Methods to evaluate effective aseptic technique Key Takeaways: - Gain a comprehensive overview of aseptic technique fundamentals - Access a graded quiz for training record validation Equip yourself with the knowledge and skills to ensure manufacturing excellence. Register now and embrace the rigor of aseptic technique! ???https://lnkd.in/ejBe3Q_n #AsepticTechnique #PharmaceuticalManufacturing #Webinar #ContinuingEducation #ManufacturingExcellence
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Join us for this engaging webinar session, “Back to Basics: Media Growth Promotion” host by Robert Westney, M.S., RAC-Drug, CMQ-OE, PA Laboratory Director at FOCUS Laboratories. We'll revisit the foundational elements of growth promotion and review both U.S. and international regulatory requirements, including the use of in-house microbial isolates. Additionally, we'll cover how to determine if your results meet acceptance criteria, how to handle unexpected outcomes, and share real-world examples of challenges and solutions in growth promotion processes. Register Today! #microbiology #webinar #mediagrowthpromotion
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Join us for this engaging webinar session, “Back to Basics: Media Growth Promotion” host by Robert Westney, M.S., RAC-Drug, CMQ-OE, PA Laboratory Director at FOCUS Laboratories. We'll revisit the foundational elements of growth promotion and review both U.S. and international regulatory requirements, including the use of in-house microbial isolates. Additionally, we'll cover how to determine if your results meet acceptance criteria, how to handle unexpected outcomes, and share real-world examples of challenges and solutions in growth promotion processes. Register Today! #microbiology #webinar #mediagrowthpromotion
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Join us with Anthony Grilli and Robert Westney, M.S., RAC-Drug, CMQ-OE for a Complimentary Webinar! Thursday, July 18 | 1pm - 2pm EST Register today to review validating antimicrobial instrument efficiency, providing knowledge and methods to ensure strong, successful disinfection procedures. What You’ll Walk Away With: Learn disinfectant efficacy testing’s role in preventing contamination, ensuring safety for products and staff. How To Verify: Discover procedures and innovative technology for evaluating and enhancing your antimicrobial equipment’s effectiveness. REGISTER HERE: https://lnkd.in/gTmriB-t
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