Recent threats such as COVID-19 Pandemic has created serious public health risks, Government and national vulnerabilities. Public institutions such as hospitals, clinics and elderly care facilities are especially at risk. Early warning, detection and rapid response is crucial in preventing an outbreak. The ability to rapidly recognize an emerging infectious disease and public health threat…
Novatek Chapter Contribution:Chapter 25: Acquisition and Implementation of an Environmental Monitoring Software ProgramBy Susan Cleary and Parsa Famili Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for…
Novatek Contributing Chapter: Medical Devices Design Based on EBD: A Case StudyBy Aram Montazami Novatek International is very proud to announce that Mr. Aram Montazami, Vice president of R&D at Novatek International has contributed to the recent Springer publication: Biomedical Engineering: Health Care Systems, Technology and Technique. The Biomedical Engineering series is an edited volume with contributions…
Novatek Chapter Contribution:Chapter 16: Automation of Environmental Monitoring: Achieving Efficiency and ControlBy Susan B. Cleary and Parsa Famili Novatek International is very proud to once again announce that Ms. Susan Cleary, Associate Directors of R&D and Mr. Parsa Famili, President and CEO at Novatek International have contributed to the recent PDA publication: Environmental Monitoring, Volume 6,…
Novatek Chapter Contribution:Risk Based Environmental Monitoring in Aseptic Processing, in the Era of Big Data By Parsa Famili, Susan Cleary and Marsha Hardiman. Novatek International is very proud to announce that Mr. Parsa Famili, President and CEO and Ms. Susan Cleary, Associate Directors of R&D at Novatek International together with Ms. Marsha Hardiman (Concordia Valsource) have…
Novatek Chapter Contribution:Chapter 6: Contamination Control Using A Risk-based, Automated Cleaning Validation Software SystemBy Parsa Famili and Susan Cleary Continuing our contribution for 2017, Novatek International is pleased to announce that Mr. Parsa Famili, President and CEO and Ms. Susan Cleary, Associate Directors of R&D at Novatek International have contributed to the most recent Environmental Monitoring…
Novatek Chapter Contribution:User Requirements and Implementation of a Risk-Based, Compliant Stability Management SystemBy Parsa Famili, Susan Cleary, & Pedro Jorge Novatek International is pleased to contribute to the 2018 edition of Methods for Stability Testing of Pharmaceuticals. Featuring contributions from labs around to globe to ensure thorough coverage of a wide variety of successful stability programs, this…
Novatek Chapter Contribution:Chapter 16 – Data Management Section for Environmental Monitoring by Jeanne Moldenhauer The first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. Modeled on the first edition, the 2008 completely revised and extended edition raises the bar by offering practical and current industrial and…
Wednesday June 15th, 2016 2:00 PM – 3:00 PM EST Stay in touch with the best practices in Cleaning Validation. This webinar will outline a Risk-Based Life cycle approach to Cleaning Validation. We will discuss Risk Management components for design and development of Cleaning Validation Programs and approaches. Topics covered include: Understand current Cleaning Validation…
Novatek Presentation: Trending EM Data and Considerations for Automation Novatek Case Study: How Pattern Recognition and Trending Assist in Root Cause Analysis Key Learnings: This case study is a real world exercise on how a to use a process based automated system to determine the root cause of multiple contamination events in a Grade D room. The…
