Ep16 - FDA's QMM Program

Mike Kowolenko, Juan Torres, and John Ward discuss how FDA investigations can benefit all parties in the industry if they are backed by science.

Mike Kowolenko, Juan Torres, and John Ward continue their discussion from Episode 17 on validation in today's data-driven manufacturing environment.

In this episode Mike Kowolenko, Juan Torres, and John Ward discuss the relevance of older validation methods in today's biopharma manufacturing data-driven process environment.

In this episode, NoviSystems CEO, Mike Kowolenko, and Chief Quality Advisor, Juan Torres, explore the FDA's Quality Management Maturity program, what it means for biopharma manufacturing operations, and its objective to reduce drug shortages.

In this episode, Dr Mike Kowolenko discusses the NoviSystems origin story and the requirements for our Fusion Analytics for Quality Systems products.

Mike Kowolenko discusses the role of data scientists, how they can contribute to a biopharma manufacturing organization and how to utilize them to achieve both their effectiveness and their retention. NoviSystems builds system to reduce the time and costs required to perform the batch release process. Contact us at [email protected] to learn more.

Dr. Mike Kowolenko discusses the benefits of digital transformation and data-driven decision-making in the drug release process - including the opportunity to reduce the time and effort required.

In this episode Mike Kowolenko and Juan Torres explore the external forces that make change a requirement in quality systems.

Mike Kowolenko and Juan Torres discuss how to manage the fear of change in quality organizations including why change should occur, pressures against change, and how to overcome these pressures. If you have questions, comments, or topics you would like for us to address in the area of manufacturing and quality in biopharma, send us a note at [email protected]. NoviSystems builds AI systems that reduce the time and costs associated with drug product release with the added benefit of unifying all organizational data for more effective and efficient management review. Contact us at [email protected] to learn more.

In this episode, Mike Kowolenko and Juan Torres dig deeper into the process of management review from the perspective that it's an opportunity to improve the organization and it's good business. This leads to ensuring the managers have the proper tools to process all the organization's data to support good decisions.