The regulations are evolving as are the processes we use to validate and monitor controlled areas and utility systems. Automating these processes and digitizing the data is a must to ensure regulatory compliance and process control. This session will review the regulations regarding the trending and data analysis requirements and which trending tools are applicable…
This is event is a FREE and LIVE on Dec. 1, 2021 ! Current regulatory thinking about environmental monitoring as outlined in the 2020 Draft of EU Annex 1 focuses on risk assessment across all the key elements of the program. This includes understanding airflows to select risk-based sampling sites, criteria for monitoring equipment, level…
Risk-Based Approach in Implementing LIMS and QMS (Webinar) / Phương pháp tiếp cận dựa trên rủi ro trong việc triển khai LIMS và QMS (Hội thảo trên web) Date and Time (Ngày Giờ) (Quản lý chất lượng – số hoá) e-QMS : 28 October 2021 (Thursday), 9:50 AM -12:00 noon ( Hệ thống quản lý…
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…
Benefits & Risk Based Approach in the Implementation of LIMS Laboratory Information management System (LIMS) has enabled laboratories to cut back manual and time-consuming activities. LIMS allows for accountability and reliability between inter-related and interdependent departments, provides seamless integration between laboratory testing, scheduling, data collection, and real-time reporting. The purpose of these 2 half-days webinar…
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…
Novatek is proud to sponsor ISPE’s upcoming webinar: 503B Compounding Pharmacies: Principles, GMPs and Case Studies Complimentary Learning Level: Advanced Time: 1100 – 1300 ET Session Length: 2 hours In the early 2010s, there were several scandals with adulterated drugs compounded in pharmacies. Hundreds of patients were infected and several of them died. Inspections…
Novatek is pleased to be an annual sponsor for the PDA West Coast Chapter for 2021! This webinar looks at the latest published draft of EU GMP Annex 1 and considers the key changes, in terms of risk philosophy, contamination control, technology and regulatory thinking. The webinar addresses: Contamination control strategy Quality systems and how…
We are proud to be collaborating again with the very active ISPE India Chapter this December! With over 40+ webinars under their belt in response to the Global Pandemic, we are so glad we can work with the Chapter to continue the training and development of our industry peers. ISPE India Pharma Best Practices Webinar…
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…