Achieving Compliance

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 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 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

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

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

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

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

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

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

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 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,

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

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

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

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

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® 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

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? 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

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

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

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

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

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

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

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

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

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

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

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

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