The BioPharma Quality Systems Podcast
Activity Overview
Episode publication activity over the past year
Episodes
Ep19 - Science-backed FDA Investigations
06 Dec 2022
Contributed by Lukas
Mike Kowolenko, Juan Torres, and John Ward discuss how FDA investigations can benefit all parties in the industry if they are backed by science.
Ep18 - Validation in Today's Data-Driven Environment - Part 2
29 Nov 2022
Contributed by Lukas
Mike Kowolenko, Juan Torres, and John Ward continue their discussion from Episode 17 on validation in today's data-driven manufacturing environment.
Ep17 - Validation in Today's Data-Driven Environment
22 Nov 2022
Contributed by Lukas
In this episode Mike Kowolenko, Juan Torres, and John Ward discuss the relevance of older validation methods in today's biopharma manufacturing data-d...
Ep16 - FDA's QMM Program
15 Nov 2022
Contributed by Lukas
In this episode, NoviSystems CEO, Mike Kowolenko, and Chief Quality Advisor, Juan Torres, explore the FDA's Quality Management Maturity program, what ...
Ep15 - Origins of NoviSystems
08 Nov 2022
Contributed by Lukas
In this episode, Dr Mike Kowolenko discusses the NoviSystems origin story and the requirements for our Fusion Analytics for Quality Systems products.
Ep14 - Working with Data Scientists
02 Nov 2022
Contributed by Lukas
Mike Kowolenko discusses the role of data scientists, how they can contribute to a biopharma manufacturing organization and how to utilize them to ach...
Ep13 - Digital Transformation for Drug Product Release
25 Oct 2022
Contributed by Lukas
Dr. Mike Kowolenko discusses the benefits of digital transformation and data-driven decision-making in the drug release process - including the opport...
Ep12 - Change is a Requirement for Quality
18 Oct 2022
Contributed by Lukas
In this episode Mike Kowolenko and Juan Torres explore the external forces that make change a requirement in quality systems.
Ep11 - Managing Fear of Change in Quality Organizations
11 Oct 2022
Contributed by Lukas
Mike Kowolenko and Juan Torres discuss how to manage the fear of change in quality organizations including why change should occur, pressures against ...
Ep10 - Management Review is Good Business
04 Oct 2022
Contributed by Lukas
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 impr...
Ep9 - Product Release with AI and Machine Learning
27 Sep 2022
Contributed by Lukas
Mike Kowolenko (CEO of NoviSystems) and Juan Torres (NoviSystems Chief Quality Advisor) explore the use of AI and Machine Learning in the product batc...
Ep8 - The Product is the Process
21 Sep 2022
Contributed by Lukas
Mike Kowolenko and Juan Torres discuss the relevance of the concept "The Product is the Process" in BioPharma quality given today's advanced analytics...
Ep7 - Quality, Innovation, and Culture
13 Sep 2022
Contributed by Lukas
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 Off...
Ep6 - Machine Learning
06 Sep 2022
Contributed by Lukas
Machine Learning is an exciting AI tool that has great potential for biopharma manufacturing if deployed properly. In this episode, Dr Mike Kowolenko ...
Ep5 - Management Review
30 Mar 2022
Contributed by Lukas
Does your organization simply assess the effectiveness of how well processes are followed? Learn how assessing the content of the processes leads to a...
Ep4 - Corrective and Preventive Actions
30 Mar 2022
Contributed by Lukas
Avoid designing Corrective and Preventive Actions (CAPAs) that simply require more human intervention and training. Instead, consider the root cause o...
Ep3 - Data Driven Decision Making for Drug Product Release
03 Mar 2022
Contributed by Lukas
Explore the complexities of releasing a batch of drug product and how to apply data driven decision making to enhance operations.
Ep2 - Proving Compliance and State of Control
13 Feb 2022
Contributed by Lukas
Explore how to use your data - numeric, categorical, and text - to demonstrate compliance and state of control.
Ep1 - Quality vs Manufacturing
13 Feb 2022
Contributed by Lukas
Explore the relationship between quality and manufacturing teams in a biopharma manufacturing organization and learn how analytics can be used to impr...