Bridging the ‘Valley of Death’ for U.S. Biomanufacturing
Biopharmaceutical manufacturing uses living cells to produce therapies that treat diseases like cancer, diabetes, and autoimmune disorders.
Recent Legislative Impacts to Telemedicine in Care Delivery
Legislative support is growing for the reimbursement of care delivery via telemedicine.
Quality Digest Top Stories for 2019
As usual with Quality Digest’s diverse audience, this year’s top stories covered a wide range of topics applicable to quality professionals. From hardware to software, from standards to risk management, from China trade to FDA regulations.
An Action Plan for Work-Family Balance
Eric, a 40-something married father of three, runs a successful startup. Given his demanding career, he and his wife decided she would be a stay-at-home mum.
Medical Errors Still Harm Too Many People, But There Are Glimpses of Real Change
In late November 1999, a TV producer called me about an alarming report that 44,000 to 98,000 A
Weekly Quizzes for Current Good Manufacturing Practices Training Credit
Weekly CGMP Quiz 1: Part 210 & 211 Subpart A General Provisions. Use with your team for training credit!
FDA’s Fast-Track Model for Software As a Medical Device Requires a Cuture of Quality
Software as a medical device (SaMD) is a growing sector in medical device technology.
Turning the Pharmaceutical Model Upside Down
The company Grace Science was born through an inversion of the normal business sequence.
Big Food Is Ripe for a Revolution
In May 2019, a California jury found Monsanto’s weed killer, Roundup, to be a “substantial factor” in the cancer suffered by a couple and ordered the U.S. agrochemical company to pay them $2 billion in damages.
Measuring Surgical Quality
Any patient scheduled for surgery hopes, and maybe assumes, that his surgeon will do a high-quality job. Surgeons know better.
