Technology Transfer Project Management Best Practices in the Era of COVID-19

December 30, 2020 || Charlie Maher

Technology transfer is essential to advancing pharmaceutical products from development, through clinical and into commercial operation.  The complexity of transferring the production of a product from a sending unit to the receiving unit is challenging even in the best of conditions. Since the onset of the COVID-19 pandemic the industry…

Understanding Failure to Ensure Proactive Maintenance

July 30, 2020 ||

In today’s highly competitive environment, eliminating unplanned downtime is more important than ever, especially when that downtime occurs during a batch that places the product at risk. Did you know “best-in-class” maintenance organizations spend 90% of their total maintenance time on proactive maintenance (planned, kitted and scheduled corrective, preventive, and…

You Can’t Distance From Quality

June 15, 2020 ||

As an essential business, which must continue functioning in the current global environment, Pharmaceutical Manufacturing companies face unique challenges. Pharmaceutical Manufacturing relies on operating in a controlled state, which stems from Quality Systems in six significant areas. With the current COVID-19 outbreak, this may require adjustments to the way the…

Is CSA Really a Game Changer for the Life Science Industry?

June 11, 2020 ||

Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software Guidance – Is it the solution to arduous validations that the life science industry has been waiting for from the FDA? Least Burdensome Approach to Validation – the Food and Drug Administration (FDA) has been pushing this concept onto…