An FDA audit doesn’t have to be a stressful event if companies are prepared with strong quality systems, complete documentation, and a proactive compliance culture.
Business decisions on quality are not always based on facts but on power dynamics, explainss Ekaterina Potemkina, Quality Mindset Activator, in a recent blog post.
Finance and commercial professionals should play a bigger role in management system standard (MSS) audits, writes Wilson Fernández, IMS Leader at QPro Australia Pty Ltd.
The IFRS Sustainability Standards, developed by the IFRS Foundation, are quickly becoming the global benchmark for climate related risks reporting with 36 jurisdictions already adopting them.
Michael Mills, a pragmatic quality leader and quality management systems expert, explores in his new blog post what ISO 9001’s climate change clause means for smaller companies.
The European Union has released draft revisions to Chapter 4 of the Good Manufacturing Practice (GMP) guideline on documentation, part of EudraLex Volume 4 for medicinal products.