The Compliance Blog

CAPA (Corrective and Preventive Actions) are at the heart of any sound quality management system.  By definition, CAPA processes ensure that you identify nonconformances, take

Savvy companies understand that Quality Assurance (QA) must be seamlessly integrated into the clinical development process rather than being an afterthought confined to audits and

Introduction to the QMSR Risk Management TransitionIt All Starts with RiskHow to Show Proper Risk Incorporation Contact Us Introduction to the QMSR Risk Management Transition The

In the dynamic and high-stakes world of life sciences, maintaining a consistent and robust quality culture is not just a goal—it’s a necessity. A leading

The notion that the role of Integrated Quality Assurance Systems in clinical development should be relegated to reviews, audits, and quality control (QC) checks is

Definitions matter.  In cases of compliance, they matter a lot.  That is why it is worth spending some focused time reviewing the QMSR transition definitional

Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of Manufacturing, Quality, Supply Chain, Technical Operations Executives, and other industry professionals. These

From the Top: Key Differences in the QSR transition to QMSR This is the second in a series of articles concerning the FDA’s proposal to transition

From May 13th to 15th, Compliance Architects attended the 2024 Pharma Manufacturing World Summit. The event gathers SVPs and VPs of Manufacturing, Quality, Supply Chain,

What is CRPN Quality Roadmap®? There was a moment in my career as a regional VP of Quality responsible for several large production sites, 25

This is the first in a series of articles on the new Quality Management System Regulation (QMSR).  The QMSR was published as a final rule

In today's FDA-regulated life sciences sector, where quality and compliance are not merely objectives but imperatives, robust quality planning should be a foundational activity to

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 build

The Cost of Poor Quality (COPQ) in the healthcare sector—particularly in medical devices, pharmaceuticals, and biopharmaceuticals—has profound implications for patients, employees, and shareholders. This analysis

Introduction The Early Days: First Approvals and Breakthroughs Cell and Gene Therapy Evolution and Expanding Applications Worth Investing in Cell and Gene therapy?  Overcoming Challenges and Barriers Complex Manufacturing Processes Quality

IntroductionOverviewThe Basics of Gene Therapy Understanding Gene TherapyThe Mechanisms Behind Gene TherapyThe Regulatory Landscape of Gene TherapyContact Us Introduction In 1991, James Watson said, “Many

Cell therapy and gene therapy are cutting-edge approaches in modern medicine, aiming to treat or potentially cure diseases at a fundamental level. Cell therapy involves

In the evolving landscape of pharmaceutical regulation, the recent GDUFA III changes introduced by the FDA promise to enhance the submission and amendment process for

In my previous article, EU MDR Implementation: Important Dates and Challenges, we examined the effects of the new EU MDR on medical device manufacturers. The

The FDA has released a draft guidance titled "Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings." The document offers valuable insights and

At Compliance Architects®, we take pride in our team of experienced experts. They are dedicated to handling the challenges of Cell and Gene Therapy (CGT).

In session 4 of our Executive GxP Training program, Teresa Gorecki discusses understanding and managing the regulatory compliance risks to your business​. The two provide

In session 3 of the Executive GxP Training, Teresa Gorecki and Jamie Colgin discuss how GMP compliance applies to companies that have outsourced all manufacturing

In today’s rapidly evolving regulatory landscape, ensuring a robust quality culture is essential for any organization in the biopharmaceutical industry. Our latest infographic, “NAVIGATING YOUR

The New 15% Rule The Components of the 15% RuleSystemsConsultantsCultureTimeFinal Thoughts on the Cost of a Warning LetterContact Us The New 15% Rule  Unfortunately, Warning Letters

Joseph Juran once defined a Quality Culture as “a culture throughout the organization that continually views quality as a primary goal. It represents the emotional

In Teresa Gorecki's second session of Executive-level GxP training, the two reviewed Regulatory Compliance Fundamentals for Early-Stage Development​, emphasizing the importance of data integrity. Evolving

To navigate FDA warning letters amidst this complex landscape of regulations can often feel overwhelming. With over 3,300 warning letters issued by the FDA since

In the ever-evolving landscape of pharmaceuticals, innovation is not just a buzzword but a critical driver of progress. Recently, the FDA introduced a draft guidance

Maintaining a robust quality culture cannot be overstated in the high-stakes world of life science manufacturing. The FDA-regulated industry is characterized by stringent requirements that

In this 4 part series, we are talking through GxP Best practices This article reviews the key highlights from Teresa Gorecki's Executive GxP training, Session

In the realm of clinical research oversight, adherence to regulatory standards is not merely a recommendation but a fundamental obligation. Recently, a significant development underscores

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of drugs and devices. One of the key

“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical

The World Health Organization (WHO) has introduced a groundbreaking global database of medical devices known as MeDevIS (Medical Devices Information System). This innovative platform boasts

Quality Culture- Everybody wants it, and many say they have it. It begins with a diagnosis… Flash Back To 1964Fast Forward To 2014TodayRecommended Process for

Hello again, everyone. Welcome to another episode of Executive Platforms' Blueprint Podcast Series. I'm Geoff Micks, Head of Content and Research. Today, Teresa Gorecki from

Maintaining a regulatory compliance strategy is crucial for any company's sustainability and success in a rapidly evolving regulatory environment. When faced with substantial challenges, Compliance

The U.S. Food and Drug Administration (FDA) has issued new guidance detailing how it will assign goal dates for abbreviated new drug applications (ANDAs) based

This is the third in a series of articles on Quality Culture in the Medical Device Industry. Read article 1 here: Why is Achieving a

Based on my recent discussions with clients and industry stakeholders, the consequences of the Supreme Court's recent Loper Bright v. Raimondo decision have become significant

The implementation European Union Medical Device Regulation (EU MDR) has had a profound impact on the medical device industry. Compliance with this EU MDR implementation,

This is the second in a series of articles on Quality Culture in the Medical Device Industry. For the first article in the series, click

A Quality Professional’s Perspective on why Change Management Efforts Fail Top Management Support Resistance to Change Failure to Address Stakeholder Concerns Conclusion Contact Us A Quality Professional’s Perspective on why

At Compliance Architects LLC, we don’t just provide top-notch quality compliance solutions; we celebrate the people who make these services possible. Our team is the

Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the

“How did you go bankrupt?” Bill asked.   “Two ways,” Mike said. “Gradually and then suddenly.”   -Ernest Hemingway, The Sun Also Rises.  Gradually, Then SuddenlyA Slow, Rippling,

Organ transplantation stands as a sign of hope for those battling organ failure, yet the chance of rejection continues to haunt the success of these

Our practice lead, Teresa Gorecki, recently shared her LinkedIn article that addresses new medical device regulation changes with a recent FDA rule on medical device

The U.S. Food and Drug Administration (FDA) has introduced industry guidance that outlines the Platform Technology Designation Program, designed to bring efficiencies to drug development,

In a new development for global pharmaceutical regulation, the FDA and the European Medicines Agency (EMA) recently collaborated for the first time on quality assessments

The business term "Operationalize a Quality Agreement" stems from my dual background as an attorney and an engineer, with extensive experience in contract work. Contracts

Diluks De Silva was honored to speak with Geoff Mix, Head of Content and Research for the Executive Platforms' Blueprint podcast series. Usually, it's Jack

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

We enjoyed our very own Teresa Gorecki, Practice Lead at Compliance Architects, speaking with Geoff Mix, Head of Content and Research for Executive Platforms, when

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

Preventing batch failures and protecting your business is crucial to success within the manufacturing industry. Insights from In-Pharmatechnologist.com (dated 4/25/2012) shed light on revelations from

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

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

As a plant-floor engineer, I've witnessed the inner workings of pharmaceuticals, medical devices, and other regulated manufacturing operations. Before my career shift toward quality culture

FDA inspection readiness is always a hot topic within the life sciences industry. Much attention is paid to ensuring that SOPs are in place, employees

Quality culture, a term that has been gaining traction in regulatory compliance, is taking center stage in the life sciences industry. In a recent webinar

In today’s pharmaceutical manufacturing landscape, trust is paramount. Patients rely on drug manufacturers' integrity to provide safe and effective medications to manage complex, targeted health

New requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are being phased in throughout 2024, affecting cosmetics products

In the realm of regulatory compliance, one acronym consistently looms large: CAPA or Corrective and Preventive Action. It resonates with anyone involved in FDA-regulated industries,

In the dynamic landscape of biopharmaceuticals, ensuring the potency of cellular therapy or gene therapy (CGT) products is a paramount objective. This draft guidance serves

The FDA and other global regulators rely on data reviews during inspections to determine whether a pharmaceutical or medical device manufacturer operates within regulatory requirements and expectations. The credibility

Cell and gene therapies represent a new medical frontier, offering hope for treating rare, orphan, and challenging diseases. However, the journey from development to market

In the realm of quality and compliance within pharmaceuticals, biopharmaceuticals, and combination products, I’ve frequently been asked about the crucial steps to pass an FDA

The highly anticipated FDA Decision on the Harmonization of the Medical Device Quality System Regulations with ISO 31485-2016 has been released, marking a significant development

Compliance Architects is proud to be Silver Sponsor of this year's RIC inaugural annual meeting! Our team will be attending the event March 22-23 at

The following transcript is taken from a PMWS interview with Compliance Architects CEO Jack Garvey. Jack discusses the current talent trends and what he thinks

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

It gives us great pleasure to announce that Randy Lumia has joined us as a full-time Vice President of Human Resources & Organizational Effectiveness.  As many

We are excited to announce that our CEO, Jack Garvey, has been selected by our partners QbDVision to join their newly formed board of advisors!

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 the biopharmaceutical industry or medical devices, scientific concepts do not result in products

Risk is still an important issue, and the fundamental premise is that there is so much to do. With this important issue and ever-changing landscape,

In this exclusive interview from BMWS, our CEO at Compliance Architects, Jack Garvey, will be expanding upon some of the most common biopharmaceutical issues and

The following article covers a transcript during training done by Teresa Gorecki and Kenneth Ray, where they discuss how Quality Pulse aligns with ICH Q10.

The following article is taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges

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

The article below is a transcript taken from June 15th Webinar - "Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality

In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business as usual. But recently progress has

The following article covers a transcript taken from June 15th Webinar - "Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality

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. QbDVision Platform

The following article a transcript from the "How is Quality Pulse different from other tools on the market?" video with Teresa, Kenneth, and Jerry. Jerry

Learn more about Quality Pulse, the FDA-regulated industry's first and most advanced quality culture diagnostic and assessment methodology, and its technical capabilities below. Quality Pulse®

Learn about how the interactive/ visual data output of Quality Pulse can benefit executives in the video and article below. Good executives make decisions based

Biden's Search for a New FDA CommissionerNo Win RolesHeads of QualityConclusionContact Us Biden's Search for a New FDA Commissioner It appears the Biden administration is

Quality Pulse® compares to other quality culture assessments in four key areas and differentiates itself quite well. Research-Based ModelPersonal ExperienceCulture MeasurementsTipping Point IdentifiersQuality Pulse Contact

The following information is taken from the February 2021 AGXPE New England Chapter live webinar. The portion below discusses the vitality of effective writing for

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 CollaborationVQA CultureQuality PulseContact Us Carmody Quality Solutions Collaboration Carmody Quality Solutions, LLC (CQS), a consulting partner that provides quality management services to

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 FDA risk management is something I live in every single day. I think it's really important to understand that when people

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

Navigating the challenges of staffing within FDA-regulated companies requires strategic considerations to avoid setbacks and maintain operational excellence. From the opportunity costs associated with internal

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

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

Are you a device or combination products manufacturer or service provider? 21 CFR 820 Connected to ISO 13485 AAMI has just released an important document

FDA inspection risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies.  While it is often challenging for medical product

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

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 the

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. Navigating FDA Guidance on Public

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

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

On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory guidance for agency practice by

On Thursday, December 7, Deputy Assistant US Attorney General Ethan P. Davis, US Department of Justice, Consumer Protection Branch, gave a speech at the Food

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 FDA live review inspection information was included in our July email newsletter. There are many training sessions conducted each year by GMP Training

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 inspection 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, a software company, headquartered in Dublin, Ireland.   The company contacted me to introduce

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 FDA

The new FDA Inspections Database 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

This is an UPDATE to a post from May 2010.Please click this link for the original post. IPhone UpdateDownloading FDA GMP/ QSR EbooksContact Us IPhone

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, dietary

“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

FDA GMP / QSR EbooksDownloading FDA GMP/ QSR EbooksContact Us FDA GMP / QSR Ebooks Aren't the IPhone and the IPad great?? All of the

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 HomesGMPs:  Design Document or Checklist?Given this, it’s no wonder why there is a poor track record of compliance within FDA-regulated industry.Design for Compliance

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:

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

The following transcript is taken from Business Intelligence Solutions Interview that talks about FDA Inspection Readiness. with Jack Garvey What are the biggest issues currently

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

Event SummaryLearning TopicsMicrosoft SharePoint Event DetailsContact Us Event Summary New Jersey based pharmaceutical and medical device companies have a great opportunity this month to gain

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

Strategy is not something often associated with compliance operations or activities. In fact, compliance is virtually never considered strategically, and certainly the design of compliance

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 TimesDOJ Undercover Sting Nets 22 in Large Scale Foreign Corrupt Practices Act Case If you are working in a senior legal, compliance

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 program (ISF). The following Regulatory Alert provides more details on