Compliance Corner
Compliance Corner: 4 Things You Should Do Now To Prep For FDA’s New QMSR Reg
Morgan Lewis partner Dennis Gucciardo says there are steps device makers can take to make sure they’re not caught behind the 8 ball once the US FDA’s proposed Quality Management System Regulation is finalized.
Compliance Corner: Here’s How Stryker Decides Whether To Launch A Device Recall
Stryker Corp. regulatory expert Ommeed Shahrokh explains the device giant’s decision-making process around product recalls and describes what’s included in recall letters to customers.
Compliance Corner: On-Site Facility Inspections Are Back. Is Your Firm Adequately Staffed?
King & Spalding quality expert Eric Henry urges device makers to be inspection-ready by making sure the right people are in the right roles.
Compliance Corner: Don’t Sign (Or Even Hear) That Affidavit!
Device makers presented with an affidavit by the US FDA during a facility inspection should walk away as quickly as possible, King & Spalding partner Jessica Ringel advises.
Compliance Corner: Investigator Gives 7 Tips To Ensure Device Cleanliness, Cleaning Validation
The US FDA’s Tom Peter offers advice, from determining a company’s “worst-case device” to identifying contaminants that work their way into the manufacturing process – and more.
Compliance Corner: Follow These 11 Steps To Prep For FDA Regulatory Meetings
Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.
The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm
From our archives: Despite the COVID-19 pandemic severely curtailing the US FDA’s ability to conduct on-site facility inspections, it’s still vitally important for manufacturers to remain audit-ready. In this collection of a 10-part Compliance Corner series, four longtime industry experts share evergreen advice on the best and worst things firms could do during an inspection.
Compliance Corner: Device Maker Irrimax Shares 11 Tips For Acing Your Next Virtual Audit
If anyone understands the ins and outs of remote audits, it’s Christy Coleman. She’s VP of regulatory for Irrimax Corp., which has been through four virtual audits under the Medical Device Single Audit Program since the COVID-19 pandemic began. Coleman shares 11 best practices in this Compliance Corner feature.
Compliance Corner: Being MDSAP-Ready Helpful While FDA Foreign Inspections Paused, Expert Says
King & Spalding’s Eric Henry urges manufacturers – particularly ones with facilities outside the US – to be prepared for a virtual audit under the Medical Device Single Audit Program. He explains how.
Compliance Corner: Leverage MDSAP Companion Doc To Master Your Next Audit, Train Staff, Expert Advises
Longtime industry expert Connie Hoy says medtech companies that sign up for an audit through the Medical Device Single Audit Program will have a leg-up if they prepare beforehand by reading the MDSAP Companion Document. The doc can also be used to train workers on what an MDSAP auditor will be looking at and asking for.
Compliance Corner: How To Survive An FDA ‘Desk Audit’ During The COVID-19 Crisis
A former US FDA investigations branch director explains how a paper-based “desk audit” would be performed by the agency in lieu of an on-site quality systems inspection. Last month the FDA hit the pause button on in-person inspections as the coronavirus pandemic rolls on.
Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 10)
A panel of longtime industry experts offer manufacturers a list of things they should and shouldn’t do when an investigator from the US agency knocks on their facility door. In this tenth and final installment of a 10-part series, the experts explain why it’s important to be honest with investigators at all times.
You must sign in to use this functionality
Authentication.SignIn.HeadSignInHeader
Email Article
All set! This article has been sent to my@email.address.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.