Yuval Shapiro is the founder of Quality with Value Ltd. A company that provides QA/RA for Medical Devices Services.

Yuval is a Quality Assurance & Regulatory Affairs Expert and consultant for products and companies primarily related to medical devices and telecom sectors. Additionally, he is a black belt Six Sigma certified from Johnson & Johnson. 

In this podcast episode, he discusses with Yan Kugel the history and evolution of Quality and why we are witnessing the death of Quality in his opinion. Then, he explains how to save it!

Watch the full video episodes on podcast.qualistery.com

Learn about quality and GMP for the top experts in the industry at www.qualistery.com

Suzzane Studinger has been a GMP consultant for over 9 years now. In this podcast episode, she explains why she decided to leave her steady job by Roche to become an independent consultant. She also reveals what the REAL job of the consultant is, what the challenges are behind it, and gives advice for employers for making the best of their consultants.

Watch the full video episode here.

James Ainsworth is a software developer who started supporting businesses with ERP deployment and CSV about ten years ago. Besides the pharmaceutical and biotech sectors, James has experience consulting companies in other highly regulated industries such as Automotive and Fintech.

In this podcast episode, James spoke to Yan Kugel about CSV and its essential parts, about which you don't learn in training.

Here are some of the topics you will hear about:

Watch the full video episode on podcast.qualistery.com.

Master GMP on www.qualistery.com.

"QA is a service provider and not a slave of the regulations."

       -Yaron Ziv

Yaron is a pharmacist and the Head of QA at Chemipal, a medicinal distribution service provider. He is known in his community for his unconventional QA approach, making him an exceptional industry leader.

In this podcast episode, Yaron explains the fundamental role of the QA from his point of view - a service provider and not a slave of the regulations. He describes the benefit of this approach and how QA leaders can achieve that in their organizations.

The podcast is hosted by Yan Kugel and powered by Qualistery. 

In this podcast episode, Yan Kugel talked to Galit Lisaey about connecting the dots in data integrity.

Galit Lisaey is a Data Integrity consultant and Information Technology Project Manager, and Expert of 20 years.

Here are some of the points they touched during the discussion:

💡 Data life cycle and dot-connecting 

💡 The human factor in data integrity 

💡 Why people need to sit together and speak about risks 

💡 How to use audit trail correctly 

💡 How to set control points

💡 Why data integrity isn't mentioned in warning letters anymore.

Learn more about Qualistery at www.qualistery.com.

Watch the video episodes at podcast.qualistery.com.

GMP training is mandatory, but nobody explains how to conduct it correctly, effectively, or measure results.

Dominic Parry is the Director of Inspired Pharma, a company based in the UK specializing in GMP training. And in this podcast episode, he explains how to do all of the above and much more.

Here are some of the matters you will learn about in this episode:

💡 Presence vs. Virtual training

💡 How to improve virtual training

💡 How to keep people  attentive in virtual training

💡 The advantages and disadvantages of external training

💡 Why it's vital to learn from other industries as well

💡 How to evaluate training effectiveness in pharma

💡 How to make the most of external training

💡 Staying ahead of what the regulators would like to see next

💡 How to design practical training

Watch the full video episode on podcast.qualistery.com

Learn about the GMP online training offered by Qualistery at www.qualistery.com

Davidek Herron is the Head of Global Digital Platforms & Operations at Teva Pharmaceuticals.

His mission in Teva is to leverage digital technologies to get medicines to patients in need in a more efficient, quick, and safe way.

In this podcast episode, Davidek talks to Yan Kugel about the importance of digital services for pharmaceutical companies and explains why their success depends on digitalization.

He also gives precious tips on how to achieve successful digitalization in any company.

  Here are some of the topics you will hear about in this episode:  

💡 Why people are the most critical part of digitalization

💡 How to forecast Out-of-Stock situations in pharma

💡 How to help doctors identify the right medicines for the patients

💡 Why Pharma Must Embrace Change and Digitalize  

💡 Digital services on global scales  

💡 How digitalization can help companies Withstand hardships like Covid-19

💡 Why pharma is behind other industries in terms of digitalization

💡 How to encourage change and progress across an organization

💡 What is the future of the pharma industry

You can watch the full episode on podcast.qualistery.com from 2020-12-21. 

Learn more about us on www.qualistery.com

In this podcast episode, Vlatko Kantardjioski gives an amazing overview of equipment qualification in the pharmaceutical industry.

Vlatko is a Quality Assurance Specialist and served in leading positions in various equipment qualification projects.

Vlatko gives many expert tips and explains in details each stage in a pharmaceutical qualification:

- User Requirement Specifications

Watch the full video episode on podcast.quaistery.com.

Learn more about our GMP courses on www.qualistery.com.

Do you know what cloud computing is and how to validate it for pharma use? You will know by the end of this episode.

More and more software become cloud-based, and pharma is not any different. Cloud computing holds in itself immense benefits but introduces new challenges in data integrity and validation.

Borislav Milev is a CSV expert specializing in cloud computing. In this episode, Borislav will make everything about cloud computing much clearer.

Here are some of the things you will learn about, listening to, or watching this episode:

Watch the full video on podcast.qualistery.com

Risk management is a crucial part of the pharmaceutical quality management system. Unfortunately, many companies don't get it right and don't understand how to use ICH Q9 correctly.

In this podcast episode, Alex hall explains the right way to approach risk and which tools to use.

Here are some of the discussed topics:

💡 How to use ICH9 appropriately

💡 Tools to identify risks

💡 The first steps in any risk Management

💡 How to design your FMEA scoring system

💡 What is ALARP and how to use it in risk management?

💡 The Biggest Mistake People Do With FMEA

💡 What Are the Tools to Identify Risks?

Watch the video episode on podcast.qualistery.com

Master Risk Management in our live, virtual workshop- Quality Risk Management