New QMSR Risk Management Transition
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
Integrated Quality Assurance Systems: Clinical Trials
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
QMSR Transition Definitional Differences: Important Guide
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
Important Differences: 21 CFR 820 QSR transition to QMSR
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
PMWS 24: New Pharma Manufacturing Insights
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®? A Game Changer for Compliance
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
Transitioning to the Medical Device Quality Management System Regulation (QMSR)
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
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
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
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
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
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
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
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
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,
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
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
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
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,
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
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
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
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
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
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
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
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:
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
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
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