Computer system validation (CSV) is more crucial now than ever. The reason for that is the digital transformation that pharma companies undergo in recent years. Additionally, with time, equipment, and software become obsolete. Thus, you need to replace it or update the software validated by the current GMP standards.  

In this podcast episode, Daniel Milek, a CSV expert from Data Integral Ltd, provides precious guidance on how you should go about your system validations. 

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

💡 The Stages of a Successful CSV

💡 How Is CSV Different From Other Process Validations

💡 How to Train People in CSV

💡 How to Use Screenshots Right for CSV

💡 The Biggest Misconceptions With Computer Systems

Watch the full video episode on podcast.qualistery.com

GMP Professionals have to deal with deviations daily, and one must admit that it is not the best part of the day. However, deviations are a crucial part of the QMS, and one has to deal with them with care.

Not doing so can get you in trouble with regulators very quickly. In this podcast episode, Yan Kugel interviewed Paul Palmer on how to deal successfully with deviations.

Here are some of the covered topics:

💡What Types of Deviations Are There?

💡What Is the Best Process to Deal With Deviations?

💡This Is the Worst Way to Retrain Personnel

💡Here Is Why It's Important to Update SOPs

💡What is the best way to approach deviations?

Watch the full video episode on podcast.qualistery.com

Learn how to handle deviations effectively by attending our virtual live Master Class: Managing Deviations From A to Z

In this episode of The Qualitalks Podcast, Yan Kugel interviewed Thomas McMann about the role of Contractors & Consultants in the pharmaceutical industry.

Working in a permanent job has its benefits, but also being an independent contractor or consultant. This work can be fantastic for many people who work in the pharmaceutical industry, but want a change in pace or just had enough of organizational politics.

Thomas is head of contacts at EPM Scientific Switzerland, and during the podcast, he addresses the following topics:

Here are some of the things Thomas told me about:

💡 Who should consider becoming an independent consultant

💡 What are the advantages and challenges of independence?

💡 What roles are there for pharma quality experts

💡 How many years of experience do you need in pharma before you can become an independent consultant?

💡 Why CSV is such a hot topic right now

💡 How to start-up your consultancy career

💡 How to find the best contracts

💡 What can you expect to earn

In this episode of The Qualitalks Podcast, Yan Kugel talked to Dr. Rhett Pascual, Ken Toley, and Dr. David Guy Brizan. They are the team responsible for CALIDAD AI, a company changing how GMP inspectors will conduct their audits.

Here are some of the things that you will learn about in the podcast:

💡 Why Auditors Need Electronic Help

💡 Why It Is the Right Time for Pharma to Digitize

💡 How AI Can Help You During an Audit

💡 What Really Stops Pharma From Digitalizing?

💡 The Cost of Not Spending on Quality Is High

Watch the full video episode on podcast.qualistery.com

Quality indeed means doing it right when no one is looking. However, preparing well for a regulatory audit is a vital task. A good preparation may turn the tides around and save you from critical findings.

In this episode, I've interviewed Paul Palmer on how to prepare correctly for a regulatory audit. Paul has been in the Pharmaceutical industry since 1986. He is a QP, a consultant, and a business advisor.

Here are some of the things, that you will learn about in the podcast:

💡 The Benefits of Preparing Well for an Audit

💡 Who Is Fit to Speak During an Audit?

💡 Tips on How to Use Gap Analysis for an Audit Preparation

💡 The Roles of the Audit Support Squad

💡 How to Prepare Your Warehouses for an Inspection

💡 Why Even the Finance Department Should Know GMP

💡 How to Choose and Prepare Subject Matter Experts When You Are Audited

Watch the video episode on podcast.qualistery.com

At Qualistery, we love talking to innovators within the pharmaceutical world. In this episode, Yan Kugel interviewed  Florian Hildebrand and Carla Peraferrer.

Florian is the CEO, and Carla is the Head of Quality at Qualifyze (Formally ChemSquare), a start-up that wants to change the way you conduct audits and qualify your suppliers. They provide auditing services across the world and believe that the future of supplier qualification lies within shared collective knowledge.

Here are some of the discussed topics:

💡 Who are Qualifyze and what is their mission?

💡 Why companies should share their audit reports globally

💡 What does qualification by the collective mean?

💡 How to adapt technologically to the pandemic reality 

💡 How to conduct a successful virtual audit 

You can watch the full video episode on 

podcast.qualistery.com or YouTube

Data integrity is a big deal nowadays, and many companies get warning letters due to non-conformities in this area.

In this podcast, Daniel Milek, a Data Integrity expert, explains what data integrity is and how to maintain it correctly.

Here are some of the discussed topics:

💡Why Data Integrity Is More Important Now Than Ever

💡What Is the Definition of Data Integrity?

💡What Are the Main Causes of Data Integrity Non-Compliance?

💡Who Are the Best People to Validate a Software?

💡What Are the Departments That Are Impacted the Most From Non-Compliance?

💡How to Write Good User Requirements Specifications

You can watch the video podcast here.

Yogesh Krishan Davé has been working in the pharmaceutical industry for more than 40 years now.

1. Training

2. Deviations and CAPA handling

Here are some of the things that you will learn about in the podcast:

💡 How to Motivate People Outside of QA to Be Part of the  Organizational Compliance

💡 Why The pharmaceutical industry should stop being arrogant

💡 How to Stop Chasing CAPAs and Wasting Men Hours

💡 How to Stop Losing Precious Time on Petty Deviations

You can watch the video episode on podcast.qualistery.com. 

Learn how to write efficient standard operation procedures (SOP) at our live virtual workshop - Writing Standard Operating Procedures (SOPs)

During his work in various pharmaceutical industry roles, Ammar Badwy has understood how difficult it is to find suppliers of raw materials that meet all the requirements. Therefore, Ammar has founded Pharmaoffer, a virtual marketplace that allows pharma companies to find qualified suppliers quickly and easily.

Here are some of the things, you will learn about in the podcast:

💡What is Pharmaoffer, and What Do They Offer?

💡Ammar's Journey from Cleanroom Repackaging to CEO

💡Why Finding New Qualified Suppliers Doesn't Have to Be Hard

💡The Future of the Digital Pharma Industry

💡Applications in Pharma Must Don't Have to Be So Complicated

In this episode of the Qualitalks Podcast, Alex Hall and Yan Kugel discussed Risk Management in the pharmaceutical industry.

Risk Management is a critical topic that is, unfortunately, misunderstood by many pharmaceutical companies. Many take the reactive approach instead of the proactive one, which can cause them a lot of money and risk customer lives. Any decision–making process about risks to product quality involves risk management to a greater or lesser extent.

Here are some of the things that we can learn in the pharma industry about Risk Management:

1. What is the definition of Risk?

2. How does it affect the pharma industry?

3. How to avoid these Risks in the pharma industry?

4. What is the Role of Upper Management?

5. What are the strategies for Risk Management?

Watch the video episode on podcast.qualistery.com

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