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 is pleased to be part of PDA TRI this year! Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines This training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such, the training course is two-fold.…
ABOUT THIS WEBINAR: This webinar will provide an overview of a holistic approach to achieve compliance with good manufacturing practice (GMP) requirements for environmental monitoring (EM) in aseptic manufacturing areas, such as ISO 5 cleanrooms in traditional setup, RABS or isolators. The new EU GMP Annex 1 (Draft 2020) requires EM programs and procedures…
FDA registered 503B outsourcing facility, Epicure a division of Stokes Healthcare has chosen Novatek’s full contamination control suite for use at their NJ, USA site. Choosing to go the extra mile in exchange for added peace of mind in compounding facilities has become pharmacy managers mandate. Novatek’s process-based solutions for Environmental Monitoring, Cleaning Validation and…
Novatek is proud to continue to sponsor and present at this year’s PharmaED Aseptic Processing Summit. Join Sheba Zaman, Novatek’s Head of Product Specialists and Training Services present on: Learn How to Trend & Analyze EM Data This presentation will cover two areas critical to the Aseptic Processing space. Part 1: EM Trending Requirements Overview…
You’re invited to Environmental Monitoring Virtual Training! Risk-Based Program Development Data Trending and Analysis HVAC System Design and Validation Risk-based environmental monitoring is a critical component for effective cleaning, disinfection programs and contamination control. Join us on August 5, where KENX and Novatek will be hosting a live virtual training, so that you can continue…
Novatek Requalified as an approved supplier for Sanofi, a global leader in healthcare. Novatek regulatory compliant quality solutions is used at Sanofi for its vaccine and other aseptic (sterile) manufacturing sites in continental US and Europe. Novatek’s solutions are dedicated to managing multiple critical aspects of a quality-controlled environment. Our software is a business ready,…
In response to COVID-19, both Novatek’s Environmental Monitoring Software and NEW Disease Control & Hygiene System are advanced analytical, and data driven technologies that supports effective quality control and reduces risk. Join us as we launch our 15 Minute Webinar Series to deliver quick and “straight to the facts” demonstrations on how to reduce your…
June 11, 2020 Read the latest press release from Novatek here: https://www.prnewswire.com/news-releases/novatek-presents-solutions-on-mitigating-vaccine-manufacturing-risks-in-response-to-covid-19-301074147.html?tc=eml_cleartime