In this podcast, John Johnson summarizes how the world’s leading pharma companies are using a variety of tools and techniques to measure and reduce the ‘Cost of Poor Quality’.

We believe remediation following a tough inspection is an opportunity to emerge stronger and more confident. Find out how by applying our 3Cs approach.

In this short podcast, John Johnson gives a summary on the proposed changes to EudraLex Volume 4, Annex 1. John gives his insight into the key parts of the update and how these may affect you, as well as providing some interpretation on how the changes may be inspected or enforced by the regulatory bodies.

Excipient GMP certification is becoming an expectation of pharmaceutical excipient customers. Catch up on this podcast from NSF's expert Jim Morris. Jim describes key elements of the standard, which areas are often cited as weaknesses and strategies for conducting an effective GMP gap assessment of an excipient manufacturer.

Reviews and compares the 2011 FDA Guidance and the recently published EU CHMP and draft GMP Annex 15 requirements for Process Validation. 

Created in collaboration with the Indian Drug Manufacturers’ Association, this unique, internationally recognized and independently assessed program has been specifically designed for Indian companies who want to succeed in U.S. and European markets, providing you and your company with what it needs to succeed. Find out more about our advanced PQM program. 

This podcast covers the trends and priorities when assuring data integrity from the perspectives of the U.S. FDA, MHRA and other regulatory bodies. 

This podcast from Martin Lush highlights the vital importance of thinking differently and becoming a disruptive and critical thinker. How do you ask bigger and better questions that take your departments and areas into better directions? Listen to the podcast to find out.

This podcast focuses on the critical prevention of errors, providing the 10 best practices to prevent errors and how to implement them in order to fix a culture of blame manufactured by a broken system. 

Look at many Warning Letters and Consent Decrees and you will see one observation often sticks out. The failure to identify root cause leading to high levels of repeat deviations.