Quality Management & Assurance

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

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

“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

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

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

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,

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

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

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

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 CDMO and CMO relationships and the whole kind of business dynamic is critically important to the life sciences space. And particularly now with what

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

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

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

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

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

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:

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

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

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

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

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