Eston Martz’s picture

By: Eston Martz

I read trade publications that cover everything from banking to biotech, looking for interesting perspectives on data analysis and statistics, especially where they pertain to quality improvement.

Michael Causey’s picture

By: Michael Causey

Just when we’d all decided Washington lawmakers won’t accomplish much beyond enjoying their own excellent health insurance coverage, tasty bean soup in the Senate cafeteria, and the best parking on Capitol Hill, it turns out they might actually unite to accomplish something pretty big after all.

Patrick Stone’s picture

By: Patrick Stone

The FDA says that investigational review boards (IRBs) aren’t required to collect a statement of investigator assurance from studies they preside over.

Michael Causey’s picture

By: Michael Causey

Jon Speer’s picture

By: Jon Speer

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a lot of emphasis on inputs and outputs, verification, transfer, and the design history file. All good things, of course; without them, you won’t meet FDA requirements for your design controls. The problem, however, is that too often people forget to ask themselves “Why?”

Larry Spears’s picture

By: Larry Spears

If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to the complexity of a quality management system for good manufacturing practices (GMP) requirements.

Kelly Kuchinski’s picture

By: Kelly Kuchinski

Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will appear on store shelves by mid-2015.

Michael Causey’s picture

By: Michael Causey

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