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Compliance Corner

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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.

Compliance Corner FDA Enforcement

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 9)

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 ninth installment of a 10-part series, the experts talk about the importance of maintaining a record of the inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 8)

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 eighth installment of a 10-part series, the experts urge firms to ask questions of the FDA’s inspection team.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 7)

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 seventh installment of a 10-part series, the experts address the use of SMEs – subject matter experts – during inspections.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 6)

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 sixth installment of a 10-part series, experts David Elder and John McKay address communication between the front room – where investigators do the majority of their work – and the back room, used by company workers to fulfill investigator requests for documents, records and other information.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 5)

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 fifth installment of a 10-part series, the experts address so-called front rooms used by manufacturers during an inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 4)

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 fourth installment of a 10-part series, the experts address so-called back rooms used by manufacturers during an inspection.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 3)

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 third installment of a 10-part series, the experts address the do’s and don’ts of responding to investigator requests for information and records.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 2)

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 second installment of a 10-part series, informational slide decks used during an inspection's opening meeting are discussed by former FDA officials David Elder and Steve Niedelman.

Compliance Corner FDA

Compliance Corner: The 10 Best – And 10 Worst – Things You Can Do When FDA Inspects Your Firm (Part 1)

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 first installment of a 10-part series, a procedure for hosting inspections is addressed.

Compliance Corner FDA

Compliance Corner: Cybersecurity Patches Aren't Recall Events – But A New 510(k) May Be Needed Over Time, Expert Says

Eric Henry with the law firm King & Spalding says that while software cybersecurity patches typically don't rise to the level of a recall, device-makers should still consider the cumulative effect of software changes on products.

Compliance Corner Cybersecurity

Compliance Corner: FDA Officials Share Tips To Ensure A Smooth Recall

Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.

Compliance Corner Recalls

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Compliance Corner FDA
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