Quality Planning for FDA-Regulated Companies: The Cornerstone of Risk-Balanced Quality and Compliance Sustainability
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
The Winchester House of Quality
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
Cost of Poor Quality (COPQ) in Healthcare
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
Cell and Gene Therapy Evolution: Groundbreaking Innovations
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
Gene Therapy Evolution: Transforming Medicine Innovation
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 vs Gene Therapy: Key Guide for Quality Leaders
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
Important GDUFA III Changes: Revisions for ANDA Submissions
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
EU MDR Article 18: Important Changes, Dates, and Challenges
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
New FDA Draft Guidance: Rare Disease Drug Development
The FDA has released a draft guidance titled "Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings."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
Meet the Amazing Cell and Gene Team at Compliance Architects
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).
GxP Best Practices Part 4: Regulatory Compliance Risks
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
GxP Best Practices Part 3: GMP Compliance in Outsourced Manufacturing
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
Navigating Your Quality Journey: Crafting a 3-Year Road Map
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 Dollar Cost of a Warning Letter: Analyzing the 15% Rule
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
Transforming Success: Building a Quality Culture from the Ground Up
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
GxP Best Practices Part 2: Early Stage Tips for Data Integrity
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
Navigate FDA Warning Letters: 4 Main Causes from John Daley
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
Drug Development: Platform Technology Designation Program
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
What is Quality Pulse® and What Make it Unique?
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
GxP Best Practices Part 1: Outsourced Operations
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
MIT COUHES IRB Warning: Ensuring Compliance in Research
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
Breaking down FDA’s Guidance on Delaying, Denying, Limiting, or Refusing an Inspection
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
Creating a Sustainable Quality Culture: Balancing Ethics, Efficiency, and Employee Well-Being
“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
WHO Launches MeDevIS: A Medical Device Global Innovation
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
Mastering Quality Culture Assessment: A Pathway to Transforming Organizational Excellence in Pharma and Medical Devices
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
Navigating the Evolving Landscape: Pharmaceutical Manufacturing Trends
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
From Crisis to Compliance: The Strategic Overhaul that Prevented DOJ Action
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
New FDA Guidance on Facility Readiness for ANDA Submissions
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
How Executive Leaders Shape Quality Culture in Medical Device Companies
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
The Loper Bright v. Raimondo Decision: Navigating the Double-Edged Sword of Reduced Federal Regulatory Power
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
EU MDR Implementation: Important Dates and Challenges
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,
The Business Case for Achieving and Maintaining a Robust Quality Culture
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
Why Change Management Efforts Fail
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
Meet the Awesome Medical Device Team at Compliance Architects
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
Why is Achieving a Robust Quality Culture in the Medical Device Industry Challenging?
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
The Road to Poor Quality
“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,
New Advances in Organ Transplantation
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
New Medical Device Regulations with the Recent FDA Rule on Harmonization
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
Streamlining Drug Development: FDA’s Advanced Technology
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,
Collaborations in Quality Assessments and Inspections
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
How To Operationalize a Quality Agreement for FDA Success
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
Navigating Great Talent Acquisition in the Pharmaceutical Industry 2023
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
Top Reasons Why FDA Inspections Often Fail
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
Navigating FDA Regulations Post-Pandemic: Interesting Insights from Teresa Gorecki
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
Writing for FDA Compliance Success: The Greatest 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
Crucial Steps for Preventing Batch Failures and Protecting Your Business
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
Why CBD Manufacturers Should Develop GMPs Even if Absent FDA Instructions
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
Akorn v. Fresenius Merger Litigation: A Deep Dive into FDA Data Integrity
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
Assessing Quality Culture in Manufacturing: The 2- Data-Point Method
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
Mastering FDA Inspection Readiness: Key Strategies for Compliance Success
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: What Are the FDA’s Thoughts?
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
The Costly Consequences of Adulterated Drugs: A Call for Strong Regulatory Enforcement
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
Navigating the Modernization of Cosmetics Regulation Act of 2022: A Decade of Evolution and Industry Impact
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
Achieve Excellence with CAPA: Your Key to Compliance Success
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,
Understanding and Implementing Potency Assurance Strategies for Cellular and Gene Therapy Products
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
Data Integrity: The Foundation of Medical Product Manufacturing Compliance
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
Navigating the Future of CAR T Cell Therapy Development: Insights from FDA Guidance
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
Expert Tips on How To Prepare For an FDA Pre-Approval Inspection (PAI)
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
ISO 31485-2016 Exclusive Insight: How FDA Reshapes Medical Device Quality Guidelines
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
RIC Inaugural Annual Meeting: Proud & Excited to be a Silver Sponsor!
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
Current Talent Trends, and Industry Needs in the Next 5-10 Years
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
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
Welcome Randy Lumia, SPHR, SHRM-SCP to Compliance Architects®
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
John (Jack) Garvey Has Been Selected by Our Partners QbDVision to Join Their Newly Formed Board of Advisors
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!
Companies Partnering with CMOs and CDMOs: Tips on Success
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
How Does Compliance Architects® Help the Biopharmaceutical Industry Achieve Its Goals?
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
How Has Biopharmaceutical Risk Changed in Light of Recent Events?
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,
2022 Key Biopharmaceutical Issues Emerging from Executives
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
How Does Quality Pulse Align with ICH Q10?
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.
Visualizing Quality Culture Data – Analyzing 2 Scenarios
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
Quality Culture Scenarios – Good vs. Bad
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 Scientific Basis of Quality Pulse®
The article below is a transcript taken from June 15th Webinar - "Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality
Reducing FDA Enforcement Risk: The Affordable 7-Step Approach
In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business as usual. But recently progress has
A New Quality Culture Paradigm
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 and CherryCircle Software Announce Exciting, New Partnership to Drive Best-in-Class Drug Development
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
What Makes Quality Pulse Unique?
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
Quality Pulse®: Technical Capabilities
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®
How Does the Interactive / Visual Data Output of Quality Pulse Help Executives?
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
New FDA Commissioner Search: Intriguing Thoughts
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
4 Ways Quality Pulse is Different Than Other Tools on the Market
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
FDA Virtual Inspections: 3 Ways to Master Compliance
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
Quality Pulse: What Type of Companies Could Benefit?
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.
When Would A Company Consider Using Quality Pulse?
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
What Does Quality Pulse Help Organizations Understand?
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
Navigating Blunt Language and Outsourcing Operations: FDA Warning Letter Insights
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
Why is Measuring Quality Culture Important for FDA Regulated Industry?
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
Exciting Insights from FDA Regulations and Industry Trends: Reflections on FDLI’s Enforcement, Litigation, and Compliance Conference
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
Compliance Architects® Collaborates with Carmody Quality Solutions on New eBook
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
How Do You Measure Quality Culture in FDA-Regulated Industry?
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
FDA Risk Management: What Quality Executives Should Consider
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
Risky Reliance – Be Careful with FDA’s New Compliant-Manufacturing Resumption Guidance
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
Leveraging Expedited Change Control: How to Efficiently Achieve Keeping Pharma/Biotech/Device Manufacturing Facilities Open
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
6 Intriguing Reasons to Work with an Interim Expert/Executive Placement Firm
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
Risk Management and Data Integrity: Focusing on the Critical
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
Sustainable Data Integrity Outcomes: Implementing Systems, Controls, Challenges and Governance
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
Is Your Data Getting You in Trouble? A Look at FDA Requirements and Expectations
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
Consideration of ICH Guideline, Industry Norms Necessary for Compliant Clinical Quality Assurance Plan
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
Writing Powerful 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
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
Medical Device Standard ISO 13485 Connected to US 21CFR 820
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: How Quality Records and Documents Can Create Your Biggest Risk
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
FDA Inspection Results & Quality Outcome: Lack of Connection
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
FDA Data Integrity: The Secrets We Keep
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
PMA Applications: 3 Key Elements on the New FDA Guidance for Industry on Acceptance and Filing Review
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
“Refuse to Accept Policy for 510(k)s”: Critical FDA Guidance
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
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. Navigating FDA Guidance on Public
7 Key Factors: Selecting Pharmaceutical Quality Consulting Firms
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
Quality vs. Compliance in FDA-Regulated Industries: A Unified Approach
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
US DOJ’s Impact on Regulatory Guidance: Navigating Rare Uncertainty in FDA-Regulated Industries
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
Deputy Assistant US Attorney General Outlines New Approaches for Enforcement of FDA-Regulated Companies
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
Misrepresenting FDA Regulation: Popular Science’s Confusion Between Dietary Supplements and Homeopathic Remedies
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
Regulatory Reform: US Election’s Impact on FDA 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.
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 FDA live review inspection information was included in our July email newsletter. There are many training sessions conducted each year by GMP Training
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 the FDLI 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
Pharmaceutical Quality Metrics: Why to Be Concerned & What to Do
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
Our New Look: An Updated Brand Reflects Excellence, Innovation & Client-Centered Performance
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
FDA Inspection 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 inspection 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,
Compounders Compliance Challenge: Navigating FDA’s New Guidance
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
ZenDoc Evaluation: Revolutionizing FDA Document Management
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
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 FDA
New FDA Inspections Database — How Useful for FDA-Regulated Industry?
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
FDA-Regulated Companies: Is Urgency a Promise or Problem?
A couple of months ago I was engaged in a brief, friendly dialogue with one of my close friends – a college buddy – about
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. IPhone UpdateDownloading FDA GMP/ QSR EbooksContact Us IPhone
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, dietary
HACCP: Underused, Underappreciated and Exceptionally Powerful
“When everything is critical, nothing is.” Author Unknown When you think back on your career as a Quality & Compliance Executive, how many times have
Will Robinson – Soldier, Family Man, Professional, Friend – RIP
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
Free FDA GMP / QSR Ebooks for IPhone, IPad, Blackberry & Other E-Reader Devices
FDA GMP / QSR EbooksDownloading FDA GMP/ QSR EbooksContact Us FDA GMP / QSR Ebooks Aren't the IPhone and the IPad great?? All of the
Mitigating FDA Enforcement Risks: Investing in Compliance to Safeguard Shareholder Value from Non-Compliance Impact
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
Designing Your Quality System: The Risk of Using the GMPs
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
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:
Admissions of Failure – A Lesson from Google for FDA-Regulated Companies?
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
Navigating FDA Inspection Readiness: Interesting Insights from Jack Garvey
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
Navigating the New FDA Enforcement Landscape: Challenges and Strategies for Industry
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
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
New Era of FDA Enforcement: Increased Outsourcing and Offshoring
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
Sponsor Reporting of Falsified Data, A New FDA Proposed Rule
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
Leverage Microsoft SharePoint: Implementing Quality Systems
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
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
Compliance Strategy Importance
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
Helpful Compliance Software Solutions & Compliance Outsourcing
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
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
Shielding Your Company: Prevent DOJ Sting Operations
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