U.S. Food and Drug Administration (FDA) inspections or customer audits are some of the most stressful experiences from working in the life sciences industry. I worked for medical device manufacturers before joining MasterControl in 2006 and I’ve been through more than my fair share of audits and inspections. The FDA…

Only a year ago, research examined the impact of COVID-19 on trends in biopharmaceutical industry and bioprocessing and found that “use of contract manufacturing organizations (CMOs) and other outsourcing will continue to accelerate.” (1)

More than 12 months later, this prediction is proving to be accurate.

CMOs and contract development…

If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout the entire product development life cycle — a responsibility which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around…

There are many measures proactive people take to prepare for potential disasters. Buying homeowner’s insurance, packing emergency “bug-out” bags, and storing viable supplies of shelf-stable foods are just a few common examples of preparedness contingencies. As recent events have shown, a lack of preparedness during a state of panic can…

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