The FDA Ramps Up GMP Inspections

Your quality management processes are under the watchful eye of the FDA and other regulators, and it is only a matter of time until you are subject to an inspection, whether planned or unplanned. As the FDA ramps up its surveillance activities to address the COVID-19 pandemic backlog, the likelihood of an inspection grows. 

Steps for a Successful Life Science Quality Audit – Part 2

In the first blog of this series, we outlined steps that a life science manufacturer should take to conduct an efficient but comprehensive internal audit of its quality operations. In this post, we explain how a manufacturer can leverage the fundamentals of internal audit planning for external audit success. 

Steps for a Successful Life Science Quality Audit – Part 1

In part one of this two-part blog post series, we outline steps for conducting a proactive, internal audit to identify opportunities for continuous quality improvement and prepare for an external audit.  

Top 8 Change Management Tools

Change is inevitable for the Healthcare & Life Science (HLS) manufacturing industries, which are heavily regulated and frequently audited. Compliance managers, quality assurance, and quality management professionals for life science manufacturers may face many challenges in their quest to implement change.  Successfully navigating change management is especially nuanced for healthcare, life sciences, and medical device...

Audit Management of Life Science Manufacturers Improves with the Right QMS.

The phrase, “You’re getting audited” causes stress no matter what business you’re in. But even in the Life Sciences, where audits are just part of everyday life, it can cause extreme amounts of stress. The work that needs to go into prepping for an audit differentiates the Life Sciences. Even internal audits require a mountain...