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 info@novi.systems 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 podcast@novi.systems.
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 info@novi.systems 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.
Mike Kowolenko (CEO of NoviSystems) and Juan Torres (NoviSystems Chief Quality Advisor) explore the use of AI and Machine Learning in the product batch release process.
Mike Kowolenko and Juan Torres discuss the relevance of the concept "The Product is the Process" in BioPharma quality given today's advanced analytics tools.
In this episode, Mike Kowolenko, CEO of NoviSystems, is joined by Dr Juan Torres, a multi-decade quality leader who was recently the Chief Quality Officer of a top 5 biopharma company. Mike and Juan discuss the current state of quality in biopharma, the positive outcomes that can be realized for quality organizations, and some of the cultural drivers that affect the organizations response to new innovation.
Machine Learning is an exciting AI tool that has great potential for biopharma manufacturing if deployed properly. In this episode, Dr Mike Kowolenko discusses how to effectively deploy Machine Learning in biopharma manufacturing.
Does your organization simply assess the effectiveness of how well processes are followed? Learn how assessing the content of the processes leads to a more effective organization.
Avoid designing Corrective and Preventive Actions (CAPAs) that simply require more human intervention and training. Instead, consider the root cause of manufacturing deviations.
Explore the complexities of releasing a batch of drug product and how to apply data driven decision making to enhance operations.
Explore how to use your data - numeric, categorical, and text - to demonstrate compliance and state of control.
Explore the relationship between quality and manufacturing teams in a biopharma manufacturing organization and learn how analytics can be used to improve the organizations goals.
