What Does it Mean to Operationalize the Quality Agreement? – Taken from PMWS 2022
This concept of “Operationalizing the Quality Agreement” comes from my background. I'm an attorney in addition to being an engineer. I've done a lot of
What Should Companies Concentrate On When Partnering with CMOs and CDMOs?
The CDMO and CMO relationships and the whole kind of business dynamic is critically important to the life sciences space. And particularly now with what
A Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk
August: normally full of summer… sun, sand and surf. As the song goes, “summertime and the living is easy…” In 2020, COVID-19 — and more
Dedicated, Integrated Quality Assurance Systems Critical to Successful Clinical Trials
The notion that the role of Quality Assurance (QA) in clinical development should be relegated to reviews, audits and quality control (QC) checks is an
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
A Two-Data-Point Measure of Manufacturing Quality Culture
With my professional experience starting point as a plant-floor engineer, I’ve spent more than my fair share of time in pharmaceutical, medical device and other
Quality Agreements – Cornerstone of Product Supply Relationships
I worked for a Chief Quality Officer a number of years ago who always had this response when our company was contemplating movement of a
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
PHARMACEUTICAL QUALITY METRICS: Why You Should Be Concerned, And What You Should Be Doing Now
FDAnews Inspections Summit I recently had the opportunity to moderate a panel discussion on pharmaceutical quality metrics at the 10th Annual FDAnews Inspections Summit in
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’s Upcoming Quality Metrics Submission Requirement: Data Driven Decision-Making or Letting the Students Issue Their Own Report Cards?
Although Corporate America has embraced the concept of metrics and dashboards for close to 20 years now, the US Food and Drug Administration (FDA) has
The Coming Evolution of Quality Management Software — Maybe.
I had an interesting phone call today with a company named ZenDoc — www.getzendoc.com — a software company, headquartered in Dublin, Ireland. The company contacted me
Batch Failures: Significant Risk Events; Challenging Investigation Opportunities
Today's (4/25/2012) news from In-Pharmatechnologist.com (see full link below) highlights information from FDA's 2011 Warning Letter dataset. The article states that: "In fiscal 2011 the US
CAPA – The Untold Story
Try as I might in my consulting work, I can never seem to get away from CAPA. As much as I would like to help
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,
Free FDA GMP / QSR Ebooks for IPhone, IPad, Blackberry & Other E-Reader Devices
Aren't the IPhone and the IPad great?? All of the information you could possibly want, right there at your fingertips! As Quality & Compliance professionals,
The Risk of Using the GMPs to Design Your Quality System
Holmes on Homes Over the last few months, I’ve become a big fan of a TV show called Holmes on Homes. The show features super-hero
The Future is Now for Computer-Based Quality Systems
Click here to read Jack's article in GxP Lifeline by Master Control on "The Future is Now for Computer-Based Quality Systems" Text of Article Follows:
Ensuring Supply Continuity for Medically Necessary Drug Products
THE FOLLOWING POST IS FROM FDANEWS. For additional information, please see: Ensuring Supply Continuity for Medically Necessary Drug Products The ink is barely dry on
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
Compliance on a Budget: Can it be Done? What are the Risks?
Like a lot of people, when I was a younger, I always wanted the newest toy or the shiniest item in the store. An unfortunate
Outsourcing and Offshoring in a New Era of FDA Enforcement
On Thursday, March 11, 2010, Jack Garvey, Principal, Compliance Architects LLC, will be presenting an audio conference in conjunction with FXTranslations and FXConferences entitled "Outsourcing
Implementing an FDA-Regulated Quality System Using Microsoft SharePoint®
New Jersey based pharmaceutical and medical device companies have a great opportunity this month to gain some significant information on how to improve their compliance
Bioanalytical Quality Standard Initiative
Jack Garvey, Founder of Compliance Architects LLC is Co-Chair of the Bioanalytical Quality Standards Initiative. This initiative, conceived by Synomics Pharma Services, was founded to
