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

Taken from LinkedIn... "At QbDVision, we firmly believe that finding the right guides is just as important as discovering the right path. We’re incredibly fortunate

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

I think the fundamental principle for all regulated industry whether it be biopharmaceuticals, medical devices, is that scientific concepts do not result in products for

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

What are some of the common issues and trends you are hearing from biopharmaceutical executives? There were trends that were occurring before the COIVID crisis,

Gorecki: Very well. Ken, do you want to take that first? Ray: Sure, I’ll take a stab at it. If you look at Q12 and

Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that expressed values is

It’s our belief that culture poses a direct risk to life science companies. And by understanding your culture and having a predictive diagnostic model that

Edgar Schein was a researcher in the 1950s and ‘60s in organizational dynamics and came up with a model that included what the organization says

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

These two slides date back almost 20 years, and the FDA intuitively saw that culture is tremendously impactful on the outcomes of life science companies,

I want to begin before I turn it over to Ken and talk a little bit about FDA’s thoughts on quality culture. I think this

Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Still, many companies struggle to

Compliance Architects® is pleased to announce that it has partnered with CherryCircle Software to support implementation and on-going support needs of CherryCircle’s clients. CherryCircle Software

Jerry Appert: Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one

Quality Pulse® has some very robust technical capabilities that are built in and accompany the research-based behavioral model that's behind the diagnostic. A couple of

Good executives make decisions based on facts and data. The Quality Pulse® output provides basically a high-level scorecard that is then drilled down into, and

It appears the Biden administration is having difficulty with selecting a new Commissioner of Food and Drugs (FDA Commissioner). (FiercePharma Story NBC News Story Endpoint News Story) I

Quality Pulse® compares to other quality culture assessments in four key areas and differentiates itself quite well. First of all, Quality Pulse® is a research-based

Question: Thanks, Jack. That was informative. What would you consider to be the 2-3 top skills that the Training and Learning community needs to upskill

The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products.

Quality Pulse® has several use cases which it adds value to an organization. I’ll give 4 as an example, here. 1st occurs very often, a

The Quality Pulse® diagnostic tool is a tool that helps an organization understand three things, really… How clearly messages regarding quality are shared across the

I’ve read a lot of Warning Letters in my 30 years of working in FDA-regulated industry.  But one issued this week made me stop and

Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it's something that's

Now that the dust has settled from FDLI’s Enforcement, Litigation, and Compliance Conference and everyone is back to the new normal (Zoom calls, casual clothes

Carmody Quality Solutions, LLC (CQS), a consulting partner that provides quality management services to the pharmaceutical industry, announced a first-of-its-kind eBook that helps quality and

Quality culture can be extremely difficult to measure quantitatively...especially for companies regulated by the FDA. In this video, CEO Jack Garvey explains how organizations can

I love risk, and risk is something I live in every single day. I think it's really important to understand that when people talk about

Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to

For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the

The Opportunity Cost of Swapping Staff from One Project to Another: The need to constantly swap internal resources to keep projects on-track can severely limit

Cannabidiol (CBD) is the latest “it” product. Companies across the US and internationally are eager to manufacture CBD or incorporate CBD into a variety of other

The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers

Being able to present data that the FDA believes it can trust is critical to making it through an inspection unscathed. Medical product manufacturers must

Data drives the pharmaceutical and medical device industries. It informs the manufacture and release of medical products to patients and consumers, and determines which products

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.

Savvy companies already understand that Quality Assurance (QA) must be integrated into the clinical development system, not relegated to an afterthought of audits and quality

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

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

Are you a device or combination products manufacturer or service provider? AAMI has just released an important document mapping US 21CFR 820 to the Medical

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

After decades in the pharma, device, and biologics industry working in new product development quality; manufacturing quality; market quality and post market surveillance; and quality

Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs

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

By now, most everyone in FDA regulated industry is aware of Theranos, the Wall Street Journal’s John Carryrou, and his award-winning book Bad Blood: Secrets

FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance: - FDA has not changed

Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce... A critical Guidance has been issued by FDA; the new Guidance, “Refuse

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)

Selecting a pharmaceutical consultant to help your organization with GMP, quality and compliance concerns can be a daunting task for any Quality executive. This is

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

As someone with many years of experience working in and around FDA-regulated manufacturing operations, a recent LinkedIn post (March 2018) entitled “Why QUALITY Needs to

The following is a redacted transcript of a live, conference call question and answer session conducted on 16 March 2018 with a leading investment advisory

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

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

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

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.  

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

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

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

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

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

It is an axiom of marketing that a company’s brand identity is fundamental to long-term business success. It is also well-known that, on occasion, a

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

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,

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

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

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

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

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

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

A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about

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

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

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,

“When everything is critical, nothing is.” Author Unknown When you think back on your career as a Quality & Compliance Executive, how many times have

Memorial Day Week is a fitting time to learn of the passing of a professional colleague and someone that I am proud to have considered

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,

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

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

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:

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

Imagine seeing the following (imaginary)  Wall Street Journal headlines: ACME Pharmaceutical Admits Product is No Better Than Competitor CRO Co. Report Shows Poor Clinical Program

  Business Intelligence Solutions Interview with Jack Garvey FDA INSPECTION READINESS   March 2010 What are the biggest issues currently facing FDA-regulated companies when it

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

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

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

Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners

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

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

strat - e - gy [strat-i-jee] - noun skillful use of a stratagem: The salesperson's strategy was to seem always to agree with the customer.

Scale without cost. These are watchwords to modern business. I want my operations to scale with my business volumes, but I don’t want to add

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

Byline 1/19/2010, Legal Times DOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal,

Although audits, assessments and corporate compliance investigations are not something most executives get excited about, they are critical to ensuring your FDA-regulated business is ready

January 26 is the deadline for compliance with the Customs Border Protection Importer Security Filing (ISF) program.  The following Regulatory Alert provides more details on