Preparing for an FDA Pre-Approval Inspection (PAI) – “Begin with the End in Mind.”
Presented by: Teresa Gorecki, Practice Lead, Compliance Architects What is it Steven Covey said in “The 7 Habits of Highly Effective People?” “Begin with the
Essentials of Post-Inspection Actions: From FDA Notices to Criminal Prosecution | August 18, 2022 | 2:00–3:30 PM ET | Live Webinar | FDLI
Attention life science quality and compliance professionals. Mark your calendars for this Thursday, August 18th at 2PM ET! Our colleague Teresa Gorecki is presenting with four
How Has Risk Changed for the Biopharmaceutical Industry in Light of Recent Events?
Risk is still an important issue, and the fundamental premise is that there is so much to do. The science is so complex. The regulatory
Data Integrity: The Foundation of Medical Product Manufacturing Compliance
The FDA and other global regulators rely on reviews of data during inspections to determine whether a pharmaceutical or medical device manufacturer is operating within regulatory requirements and expectations.
Investigations, Analyses and Conclusions: Finalizing Well-Written, Inspection-Ready Documents
Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in
How Quality Records and Documents Create Your Biggest FDA Inspection Risk
Risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies. While it is often challenging for medical product manufacturers to
Writing: The FDA Compliance Problem No-One Talks About
There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But
New DRAFT FDA Guidance Published Today – Nonbinding Feedback
Important DRAFT FDA Guidance issued today (dated 2/19/19 however) regarding "non-binding feedback" after FDA inspections of certain medical device establishments. Limited to statutory (FDARA 704)
US DOJ Reverses Decades of Predictable Guidance to Life Sciences Industry
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory agency practice by substantially reducing
Deputy Assistant US Attorney General Outlines New Approaches for Enforcement of FDA-Regulated Companies
On Thursday, December 7, Deputy Assistant Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food and
POPULAR SCIENCE; BAD JOURNALISM
Two months ago I posted in LinkedIn about a Popular Science article that unfairly characterized FDA’s regulatory process, and implied FDA tacitly agreed with a
Trump, Regulatory Reform & FDA Compliance: The Impact of the US Election on FDA Regulatory Enforcement
The election of Donald Trump as President-Elect of the United States was, and continues to be, a watershed moment in the 200+ year American experiment.
FDA “Live Review” Inspection of Company Documentation: Are You Ready?
The following was included in our July email newsletter. There are many training sessions conducted each year by GMP Training Managers and company quality and
FDA Announces New Office of Dietary Supplement Programs (ODSP)
Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang. As many of us industry insiders have
Executive Insights from FDLI’s 2015 Enforcement, Litigation & Compliance Conference: Trends and Risks for 2016 and Beyond
Early December is one of my favorite times of year. Coming off of Thanksgiving and looking forward to the end-of-year holidays, it’s when I get
FDA’s Inspectional Authority: Inviolate or On Shaky Ground?
I just posted a response on LinkedIn to a recent LinkedIn post by John R. Fleder (from his firm's excellent FDALawBlog) surrounding FDA's inspectional authority
Smile, You’re On FDA-Camera!
The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections,
Welcome To The Party Compounders!
The September 12 edition of the industry newsletter QMN Weekly contained an article about objections voiced by the International Academy of Compounding Pharmacists (IACP) concerning
FDA Warning Letters Increase 155% from 2010 Levels
If you have any role within an FDA-regulated company, it is likely you are aware that the FDA has been much more focused on enforcement
New FDA Inspections’ Database — How Useful for FDA-Regulated Industry?
The new Inspections Database (http://www.fda.gov/ICECI/EnforcementActions/ucm222557.htm) is a positive step by FDA to provide further transparency for the public (and likely their Congressional representatives!) regarding enforcement
UPDATE: Free FDA GMP / QSR Ebooks for IPhone, IPad
This is an UPDATE to a post from May 2010. Please click this link for the original post. On Monday, June 21, Apple released the
Webinar, June 23: Inspection Readiness for a More Aggressive FDA
Join the Center for Business Intelligence for a one-hour, information-packed webinar on managing FDA inspections from a more aggressive FDA. Now that pharmaceutical, medical device,
Two Billion, One Hundred Twenty Million Dollars – The Real Cost of Non-Compliance
I’m struggling to find an answer to the following question: If you were the owner of a company, how much would you spend, year over
Interview: FDA Inspection Readiness
Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS March 2010 What are the biggest issues currently facing FDA-regulated companies when it
Tick, Tick, Tick: FDA Steps Up Criminal Investigation Activity
A review of FDA enforcement news over the last year should clearly demonstrate an important shift in approach by the FDA that the “cop” side of
FDA 483 & Warning Letter Response & Planning — DOs and DON’Ts
If you are reading this now, you are probably in the middle of an enforcement crisis. Responding to an FDA-483, Warning Letter, or in some