Novatek will be leading workshops and exhibiting at this year’s A3P workshops solely dedicated to the Cleaning Validation process. Full details on the workshop (to be provided in French and English) can be found here: https://www.a3p.org/a3p-validation-nettoyage-2022-lille
European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC), calculated based on health-based exposure limits (HBELs), a routine cleaning program to evaluate effectiveness of the steps used, followed by microbial Environmental Monitoring, Water and Utilities Monitoring, HVAC filter qualifications, Media Fills,…
Enter 2022 with the latest knowledge of automating your cleaning validation process and meeting regulations such as Data Integrity. Many are worried about updating their cleaning validation process to meet the latest Annex 1 and other regulations. You will learn how automation can help you setup your process and how you can continuously optimize your…
Novatek is pleased to be returning to Biarritz, France in-person for this year’s A3P International Congress! You can find us at Stand R20. This event will be structured, as it has been since its creation, around fifteen conferences and a round table, an exhibition of more than 90 suppliers and 16 workshops to move from…
Abordagem: DIA 17/11 9h15 às 9h30min Abertura Jamila Delfraro (Líder Comitê de Validações) e Ricardo Miranda (Presidente ISPE Brasil) 9h30min às 10h30min Principais mudanças com a introdução da Toxicologia na Qualidade pós RDC 301/19 Mariah Ultramari(Spektra Consultoria) e Jamila Delfraro (QS Pharma) 10h30min às 10h50min Coffee Break 11h às 12h Lifecycle: Design Qualification (DQ) by…
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…