This podcast presented by NSF's expert John Johnson covers why Annex 1 is being updated and what the updates are expected to achieve. He also takes a deep dive into how you can generate a contamination control strategy in your sterile production unit to help you identify and mitigate risk, and improve product quality.

Lynne Byers explores different models for managing both internal company teams across a global organization and third-party contract manufacturers. 

How do you design a risk-based and cost-effective validation program to meet cGMP expectations? This podcast provides an overview of the new science and risk-based approach to validation that is now enshrined in guidance from both the U.S. FDA and the EU.

By the end of this podcast by NSF's Pete Gough, you will understand what regulatory affairs includes and how this impacts the role of the QP and QA. 

Podcast

Is your life consumed by KPIs? Want to know how to generate measure that work for you, not the other way around? We believe less is more. If you’re suffering from death by measure this could save your life.

This podcast offers perspective on pharmaceutical quality systems 10 years after the issuance of ICH Q10 and describes the most common quality system weaknesses, ways you can assess your quality system and management’s commitment, and opportunities to consider to unlock the value of the quality management system.

How do the best companies remain inspection ready by design rather than good fortune? In this podcast, John Johnson covers what perpetual GMP compliance means and details how you and your organization can achieve it. He also introduces the basic toolkit used for inspection preparation.

There is risk in everything we do. The key to our success is how we manage it. This podcast will show you how best-in-class companies gain significant commercial and regulatory advantage by managing risk intelligently.

Companies with a blame culture will struggle to survive. Don’t be one of them.