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EU-US Mutual Recognition of GMP Inspections and Batch Certification

The EU and the USA are in the final phase of the implementation of the GMP Mutual Recognition Agreement (MRA) which will pave the way for exchanges of GMP inspection documents and usage of inspection ...

President's Impact on Pharmaceutical and Medical Industry is Still Unclear

What remains to be seen is the impact on regulating bodies such as the FDA; will the new reductions reduce the effectiveness of the FDA or spur growth opportunities as promised?

The Skills Development / Quality Culture Connection

Our Benchmarking Study shares the top priorities of companies in 2017, and this year “Improving Quality Culture” was cited most often. What’s clear from the results is that improving culture impacts people, processes and systems. Quality Assurance and Learning teams, as well as Operations, HR and IT, are making process improvements and harmonizing systems as well as modernizing their learning management strategies.

Elements of Microlearning

Microlearning, which is a way of delivering content to learners in small, very specific bursts over time or as needed, has become important from a learning and development perspective for a number of reasons.

Maintaining Manufacturing Quality

By Karl Kapp  Quality or lack of quality in a manufacturing process can lead to warning letters and serious issues with the FDA. Here is a list of several infractions found in warning letters from ...