It’s human nature to resist change, and the life sciences industry is not exempt from a change-averse mindset.

When a customer asks to see your layered process audit (LPA) documentation, will you be ready? For many manufacturers, the answer is no.

With medical cannabis being legal in Canada since 2002, and recreational use becoming legal in 2018, Prime Minister Justin Trudeau’s promise to his country has caused a storm.

In August 2011, a can of Great Value peas joined the nonperishables in my pantry, one of several panic purchases as Hurricane Irene barreled toward my home on the northeast U.S. coast.

Outsourcing is historically one of the most misunderstood concepts in quality management system (QMS) implementation and operation. Prior to ISO 9001:2015, the requirement for outsourced processes was limited to a few sentences in the standard’s clause 4.1.

Born to a Dalit family, Megha was raised in Southwest India and learned English at her convent school. As a child, she aspired to be a fashion designer or a cardiologist, but her parents insisted that she become an IT engineer.

Imagine building a brand over decades. Hundreds of millions of dollars invested in design and development. Sponsorships with celebrity athletes and professional and college teams. Leading-edge marketing making your company one of the top 20 brands in the world.

Engineers at the National Institute of Standards and Technology (NIST) needed a way to secure smart manufacturing systems using the

As the United States struggles with rising healthcare costs, reducing the amount of money pharmaceutical companies spend dealing with regulation, while at the same time meeting drug safety requirements, would seem to be competing interests.

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?