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Compliance Corner

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Compliance Corner: MDSAP Auditor Answers 5 Frequently Asked Questions

Despite being around for years and growing in popularity, there are still manufacturers that have questions about the Medical Device Single Audit Program. MDSAP auditor Brian Ludovico of NSF International answers five of those common questions here.

International Compliance Corner Compliance

Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says

A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.

Medtech Tips Quality

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.

Compliance Corner Combination Products

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.

Medtech Tips Combination Products

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.

Compliance Corner Enforcement

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.

Compliance Corner Combination Products

Compliance Corner: 8 Handy Tips From An MDSAP Auditor To Help You Ace Your Next Audit

NSF International's Brian Ludovico offers up advice for device-makers facing an audit under the Medical Device Single Audit Program.

Compliance Corner International

Investigator Horror Stories 3: Boozing On The Job? Yup, That Happened – As Have These Other Shocking Tales Of Irregular FDA Inspections

In the final chapter of our Investigator Horror Stories trilogy, former US FDA investigations branch director Ricki Chase tells how one agency investigator blatantly drank alcohol and asked for bathing suit suggestions during an audit in Greece, and longtime industry insiders Steve Niedelman and David Chesney offer up three bone-chilling stories of investigators who stepped over the line. Check out how they handled the outlandish inspections in this Compliance Corner threequel.

Compliance Corner FDA

Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA

FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer's work through a Freedom of Information Act request – and more.

Medtech Tips FDA

Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says

Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.

Medtech Tips FDA

Compliance Corner: Listen To 'DRUM' Beat When Writing An After-Inspection Response To FDA, Expert Says

Longtime device industry insider Steve Niedelman shares some best practices for drafting an effective response letter to US FDA following an unfavorable facility inspection.

Compliance Corner FDA

Compliance Corner: FDA's Boyd Gives 4 Pointers For Engaging With The Agency Post-Inspection

Sean Boyd – deputy director for regulatory affairs for the Office of Compliance within US FDA's device center – wants device-makers to take a few steps to ensure that problems identified by investigators during an inspection are adequately addressed.

Compliance Corner Compliance

Medtech Tips: Follow This Advice From FDA's Maisel For A Better Pre-Market Experience

Bill Maisel – director of the Office of Device Evaluation within US FDA's Center for Devices and Radiological Health (among other titles) – says there are four things device-makers should do to make sure they succeed during the product-review process.

Medtech Tips FDA
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