Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak
Speaking the language of both devices and drugs is an important step sometimes missed by makers of combination products. Being "bilingual" is especially important during a facility inspection by US FDA, Johnson & Johnson's Susan Neadle says.
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Compliance Corner: Having A Tight Grip On Suppliers Is Critical For Combination Product Manufacturers
Controlling vendors can be tricky for any manufacturer, but when you're a maker of combo drug-device products, it's doubly important to make sure suppliers are on the up-and-up. Experts from Johnson & Johnson and PAREXEL offer quick tips for keeping a watchful eye on vendors.
Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In
How manufacturers of drug-device combination products set up their quality system depends on various factors, including the primary mode of action – the constituent part of the product that offers the most overall benefit. So say experts from Johnson & Johnson, Eli Lilly and PAREXEL, who offer other tips and advice.
Compliance Corner: In Today's 24/7 World, Have Experts On Call For FDA Inspections, Eli Lilly Quality Director Says
Having the right subject matter experts on hand day or night is critical to acing a US FDA facility inspection, Eli Lilly's David Shore advises. In fact, to be sure it always has the right experts available to answer investigator questions, the firm has restructured its organization to include two new roles to support audits: global product stewards and global process stewards.