What to Expect from your First CMO Remote Audit

By |June 25th, 2020|COVID-19, Drug Product Manufacturing, Manufacturing, QA/QC|

Remote quality audits (sometimes called “virtual audits” or “e-audits”) are replacing the in-person quality audits that have long been an integral part of selecting a life science Contract Manufacturing Organization (CMO) or Contract Development and [...]

How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016

By |June 26th, 2019|Certifications, QA/QC, Useful Tips|

For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food and Drug Administration (FDA) has considered their Quality System Regulation (QSR) to be the minimum criteria for medical device manufacturing since [...]

Looking to Gain Value in Your Drug Product or IVD? Level-Up Your QC Program

By |February 8th, 2018|Cost, QA/QC, Useful Tips|

Many organizations view their QC program as a necessary evil- required by regulatory bodies and useful primarily to release product. However, defining and building a solid Quality Control program can unlock great value. Setting aside the need for fin [...]

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