• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Blog
  • News & Events
  • Videos
  • Resources

main-logo-small

Compliance Architects

Consulting Technology Outsourcing

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

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 a current business imperative: urgency. My friend is a Senior Partner with a large, very well-known business consulting firm, and has responsibility for major projects within large FDA-regulated companies.

Table of Contents

  • “Urgency” Book
  • “Urgency” Response
  • Establishing a Culture of Strategic Planning and Execution for FDA-Regulated Companies
  • Contact Us

“Urgency” Book

As part of our regular communications, my friend forwarded me the following “book review” that he thought would be of interest:

Latest book from John Kotter: “Urgency“

Essentially talks about how people/organizations need to develop “true urgency” as a core competency.  With the rate of change at an ever escalating pace, the traditional episodic approach to change (aka projects) will not be sufficient to sustain competitive advantage.  He describes three modes of operation:

1. not urgent — protecting the status quo 2. false urgency — frenetic activity… but not aligned, goal is to stay “busy” vs winning 3. true urgency — objective is to WIN – NOW, by doing something important everyday

“Urgency” Response

My reaction to this review was somewhat less enthusiastic than I’m sure he was hoping for.  It initially struck me as “consultant speak” and self-serving – something that I feel is all too common in consulting circles.    After thinking about it further, I think that much of the challenge facing FDA-regulated companies, and business in general, is that individuals within these FDA-regulated companies don’t challenge conventional wisdom nearly enough, and simply “lap up” the concepts presented to them.

On this topic – the topic of “urgency” – I don’t think that we aren’t moving fast enough in the business world – in fact, I think we are often doing without thinking – we respond often without seeking to understand deeper issues just because we have to get a response developed, NOW! In this context, I offered the following back to my friend:

Being the contrarian that I am, I would suggest that “Urgency” has a big price — ask Toyota or BP.  The more things change, the more they stay the same — fundamentals are key today — and failure to focus on fundamentals (culture, the long view, structural profitability, maximum asset contribution, portfolio stability and strategy, etc.) is where companies are having difficulty. It would seem that viewing business challenges as running faster on the hamster wheel is a convenient distraction to actually achieving anything that builds long-term value.

My $0.02

fda-regulated urgency

Establishing a Culture of Strategic Planning and Execution for FDA-Regulated Companies

Since that was a sound-bite, I’ll expand upon the principles I was trying to convey there. I am a strong believer in robust strategy development; open, honest communication and feedback; and comprehensive program planning and execution. Call me old-fashioned, but I’m a strong believer in fundamentals, and this is an area that I don’t think industry, and especially FDA-regulated industry focuses on enough.

I had three high-school football coaches that taught me life lessons I still embrace today (Thank you Coach Gilbo, Coach Cotter and Coach Guyette!), and one of the most important was the power of fundamentals. They used to tell me that in football, every play was meant to score a touchdown – if each person executed their blocks perfectly – the play would score. Simple. Fundamentals.

My friend responded back;

love the spar

Fact is the world has changed… no arguing the globalization and pace of continuous change we all deal with today  — due to advances in technology, the flattening of the globe, the information access afforded by the internet… etc.

Point is urgency (action towards competing the important activities — aka those that give you advantage) must be transformed from project specific and baked into the fabric of the enterprise (CULTURE)

Too many mistake “busy” for progress.

Now, I’m not exactly sure what he meant by this, but I’m guessing he bills more by the hour than me! Call me crazy, but I’m more in line with the ”Haste Makes Waste” camp than John Kotter’s (or my friend’s!) camp.

So, what do you think? Are we not moving fast enough in the FDA-regulated industry? Or are we moving too fast? Any comments are welcome!

Contact Us

For information on how to urgently address FDA compliance deficiencies and build sustainable compliance solutions within pharmaceutical, medical device and other FDA-regulated companies, please contact Compliance Architects® by filling out the form below.

Filed Under: Miscellany

Primary Sidebar

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

You May Also Like

The Road to Poor Quality

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,
What Makes Quality Pulse Unique?

What Makes Quality Pulse Unique?

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

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.

Footer

Compliance Architects®

  • Contact Us
  • (888) 734-9778
  • info@compliancearchitects.com

Quick Links

  • About Us
    • Senior Staff
    • Why Us
    • Mission And Vision
    • Clients
    • Partners
    • Career Opportunities
  • Services
    • Inspection Readiness & Enforcement
      • FDA Inspection Readiness
      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • Project/Program Management
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
    • Dietary Supplements
    • Medical Devices and Diagnostics
    • Pharmaceuticals
  • Contact Us

Our Services

  • Inspection Readiness & Enforcement
  • FDA Quality Consulting – Systems and Training
  • Quality Assurance and Engineering
  • Corporate Compliance and Litigation Services
  • FDA Regulatory Consultants – Due Diligence
  • Quality, Compliance, Regulatory & Operations’ Staffing Services

Proprietary Solutions

  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

© 2009-2025 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.

  • Debarment Certification Statement
  • Privacy Policy
  • Terms of Use

Contact Us Today

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT