Novatek is proud to be exhibiting in person at this important event! The Cleanroom Technology Conference is designed to highlight best practice and regulations affecting both cleanroom design and cleanroom operation across various sectors for those working in controlled environments and cleanrooms. The conference will cover a wide scope of industry knowledge and guidance in…
Novatek is happy to sponsor the next ISPE Webinar for our industry colleagues: Complimentary Webinar Learning Level: Intermediate Time: 1100 – 1200 ET Session Length: 1 hour The webinar will discuss the “science-based” and “risk-based” approaches to cleaning validation, and the current regulatory viewpoint. The calculation of the maximum safe carryover (MSC) will be presented and analyzed to provide understanding of the changes to the current calculations…
Knowledge Exchange Network (KENX) is very excited to announce their Validation University is returning virtually to Ireland this fall. The event is a dream come true for engineering, quality, C&Q and validation professionals by offering hands-on training for the pharmaceutical, biotech, medical device and related industries. Participants create their own experience by choosing from over…
세척 밸리데이션(Cleaning Validation)은 제약 바이오 업계의 주요 GMP 요구사항으로 그 중요성이 점점 증가하고 있습니다. 견실하고 규제를 준수하는 세척 밸리데이션 프로그램은 성공적인 제조 시설 관리라는 측면에서 기업의 성공적인 비즈니스 운영을 위해 필요합니다. 본 웨비나에서는 이러한 세척 밸리데이션을 위한 노바텍 CVM 솔루션을 소개합니다. 세척 밸리데이션 솔루션이란 무엇인지 그 중요성에 대해 설명하고 전 세계 글로벌 제약사들의 노바텍 CVM 솔루션사용 현황에 대해 소개하며 노바텍…
Many companies spend exorbitant amount of money and time on the qualification of cleanrooms and the validation of product manufactured within. KENX is proud to present a one-stop-shop for professionals tasked with the contamination control and disinfection, cleanroom design, environmental monitoring and cleaning validation practices at their facility. This hybrid conference showcases those paving the…
𝗪𝗲 𝗮𝗹𝗹 𝗸𝗻𝗼𝘄 𝘁𝗵𝗲 𝘀𝘁𝗮𝘁𝘀. 𝗥𝗼𝗯𝗼𝘁𝘀 𝗮𝗻𝗱 𝗮𝘂𝘁𝗼𝗺𝗮𝘁𝗶𝗼𝗻 𝗮𝗿𝗲 𝗲𝘅𝗽𝗲𝗰𝘁𝗲𝗱 𝘁𝗼 𝗯𝗲 𝗳𝗮𝘀𝘁𝗲𝗿 𝗮𝗻𝗱 𝘁𝗼 𝗿𝗲𝗱𝘂𝗰𝗲 𝗵𝘂𝗺𝗮𝗻 𝗲𝗿𝗿𝗼𝗿𝘀 𝗯𝘆 𝗶𝗻𝗰𝗿𝗲𝗱𝗶𝗯𝗹𝗲 𝗳𝗮𝗰𝘁𝗼𝗿𝘀. The global pandemic has accelerated the importance of speed while maintaining our standards of safety. At this first time event, PDA – Parenteral Drug Association will cover a wide range of topics ranging from artificial intelligence…
The 2021 PDA Annual Meeting promises to have something for everyone! This premier conference will offer a new ways to connect! What will remain constant is that this Conference will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through…
Strides Pharma Science Limited located in Bangalore, India has selected Novatek’s automated Cleaning Validation software tool, Nova-Cleaning Validation. From both a regulatory and industry perspective, cleaning validation is recognized as being critical for patient safety and product quality because it guarantees that product contamination is effectively controlled. Manual methods for managing the cleaning process on…
Can you implement the best science-based, risk-based, and statistics-based approaches for cleaning validation? Today’s regulators are now expecting ADE monographs and risk assessments of your organization’s cleaning validation programs. Implementing a Risk-Based, Data Integrity Compliant Cleaning Validation Management System SPEAKER: Sheba Zaman, Head of Product Specialists at Novatek International In pharmaceutical manufacturing, risk of contamination…
Novatek will be speaking at an upcoming webinar hosted by the ISPE India Affiliate Chapter. The webinar will describe the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to the lifecycle of the product manufacturing process. Establishing of health-based Cleaning Validation limits and using them in…