Medical Device Blog

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Medical Device Blog 2018-02-16T13:10:26+00:00

MEDICAL DEVICES

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  • FDA Sent These Warning Letters

FDA Sent These 4 Warning Letters for Medical Device Companies | Oct – Dec 2017

January 31st, 2018|0 Comments

We took a snapshot of the 4 warning letters the FDA sent to medical device companies last quarter.  Device manufacturing violations ranged from failing to evaluate complaints to failing to establish [...]

If You Didn’t Document It, It Didn’t Happen

January 25th, 2018|0 Comments

A Guest Post from Oliver Yu, CTO, FDAzilla A core belief of drug manufacturing is that the drug alone is not the product of the pharmaceutical company.  The drug and the documentation proving that the [...]

  • US-EU Mutual Recognition Agreement of 2017

US-EU Mutual Recognition Agreement of 2017

August 22nd, 2017|0 Comments

A Long Time in the Works by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the [...]

1408, 2018

FINAL Part 3: Invisible Ink in GLP and GCP Research

By | August 14th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|0 Comments

“I can’t promise success, but I can tell you I’ve been successful most of the time when I walk a scientist through their process. To that end, I make the following proposal, which I hope will start a conversation here and which can be continued with your company and with your service providers.”

1308, 2018

The New FDA GMP Inspection Model

By | August 13th, 2018|Categories: Biopharma / Pharma, CGMP, FDA, FDA Enforcement News, FDA Enforcement Trends, FDA Inspections, Medical Devices|2 Comments

While the drug GMPs haven’t changed much, if at all, in recent years, the FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted. Last year, the FDA made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs. This post dives deep into this model – including new timelines for those of us in the drug industry.

708, 2018

Part 2: Invisible Ink in GLP and GCP Research

By | August 7th, 2018|Categories: Biopharma / Pharma, CGMP, FDA Enforcement Trends, FDA Inspections, FDA Warning Letters, Medical Devices|0 Comments

“When I started in the industry back in 1990, I was a statistical programmer. While none of us used the phrase ‘data integrity,’ the way we worked helped ensure data integrity.” This post dives deep into these questions: What game changing regulatory action happened in 1997? Why do we validate computer systems? Are there any regulatory provisions for draft GLP or draft GCP data?