Current Contract Manufacturing Operation (CMO) Regulatory Issues

Featuring a Summary of Ben Venue Issues
Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential issue must have a corrective action with a demonstrated positive outcome. There no longer exists a prescribed sequence of events after a Form FDA 483 is issued. Contract Manufacturing Operations, in particular, must now have strategies to ensure GMP compliance at their facilities involved in “arms length” activities with innovator and generic firms and be prepared for more frequent and thorough audits. 

Novatek’s NOVA-EM

The Environmental Monitoring Data Management & Trending System Software – The Industry Standard It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was: How many people are…

Novatek International contributes again in the latest PDA publication, “Environmental Monitoring” Volume 6

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, edited by Jeanne Moldenhauer, chapter 16 “Automation of Environmental Monitoring; Achieving Efficiency and Control”, 2012. This series is an edited volume with contributions from world experts. It provides readers with unique contributions related to current research and the future of Environmental Monitoring. Practitioners and researchers focused on microbiology, research and development, quality and environmental monitoring will find this book a valuable daily reference. Ms. Cleary and Mr. Famili have previously published number of chapters and articles, notably Environmental Monitoring, Volume 2, edited by Jeanne Moldenhauer, chapter 25 “Acquisition and Implementation of an Environmental Monitoring Program”. We encourage you to read Novatek International’s latest contribution in this highly informative PDA publication.

Novatek International Travels to the Philippines

Novatek International organized an open forum with various Philippine Pharmaceutical Associations. Novatek’s objectives during this event were: To provide an update on global trends and guidelines (and present the Novatek solutions suite and examples of its capacity building activities with the pharmaceutical industry in other regions). To identify priority capacity building needs of the Philippine…

Useful Insights from the 2013 MES Product Survey | Novatek International Showcased in Supplier Listing 14th Year

Showcased for the 14th year in a row, Novatek International is pleased to be listed in this year’s edition of CGI’s, Manufacturing Execution System (MES) Product survey. With over 73 MES products from 69 different vendors, the MES Product Survey comprises extensive and detailed information about various methodologies and tools for the latest trends in…

Novatek & Cognistat Recognized by Minister of Health, Ontario Canada

Cognistat Recognized by Hon. Dr. Eric Hoskins, Minister of Health & Long Term Care, Ontario Canada | Arab Health 2016

Novatek’s rapid assessment tool, “Cognistat” has been recognized as the Global Leader in computerized Cognitive impairment assessment for the diagnosis of Alzheimer’s and dementia by Dr. Eric Hoskins, Minister of Health and Long Term Care, Ontario Canada. Arab Health was Novatek’s first stopping point of 2016!  The Middle East is very important to Novatek with…