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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.

Companies that do not have a culture supportive of enabling quality…they suffer poor health authority outcomes, there is a lack of trust amongst healthcare providers and patients, there are unplanned financial impacts as a result of aggressive remediation, or delays in new product launches. These issues exist across companies in the regulated healthcare industry, and as I said, those with a good quality culture suffer from those things to a much lesser degree or not at all.

Another thing that the companies’ would benefit for in the industry is… as the quality culture reaches toxic levels, you begin to see recalls, you begin to see more recalls, you begin to see shortages and outages, interruptions in supply chain, company reputation suffers, and I’ve seen in our industry, even company stock performance suffer, as a result of what the media chronically represents as quality issues in a given company or associated with a given brand. I certainly wouldn’t want to name names, but I have several clear examples of those companies in mind, to be honest.

Quality Pulse

quality pulse

The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life sciences companies. The methodology was developed and adapted from well-established research, including:

  • Organizational culture principles of Edgar H. Schein (MIT/Sloan);
  • System dynamics principles of Peter Senge (MIT/Sloan);
  • Dozens of research articles on corporate culture, quality culture, and organizational behavior, many in the life science context from 2000-present; and
  • Decades of direct experience in quality operations across a variety of life science (pharma/device/biotech) organizations (100-100,000 employees).

Developed specifically to help organizations of all sizes understand the drivers of their culture of quality, the methodology and outcome reporting provide actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.

To learn more about Quality Pulse click here.

Contact Us

To learn more about how Quality Pulse can apply to your business, fill out the form below to contact us.

Filed Under: Quality Culture

About Teresa Gorecki

Teresa Gorecki is a VP and Practice Lead for Compliance Architects LLC.  She has served in numerous senior and executive positions in Quality in Industry and has been an Executive Quality Consultant for over 8 years.  She has occupied Sr. Executive Leadership roles for over 15 years with extensive experience with BioPharma and Pharma products including cell and gene therapy, Medical Devices, and Combination Products.   

She has shepherded the approval of numerous monoclonal antibodies, r-DNA products, complex combination products and medical device products through the FDA approval process.  Teresa enjoys supporting the virtual start-up companies in BioPharma and novel Pharma as they progress from pre-clinical development through clinical development and FDA/global health authority approvals.  She has created a novel, risk-based approach to the development of a “fit for purpose” quality management system for companies in clinical development that is phase-appropriate. 

Teresa also has deep experience leading and managing general and for cause FDA inspections, preparation of 483 and Warning Letters Responses as well as pre-approval inspections. She has developed quality and compliance strategies for her clients to prevent the issuance of Warning Letters or referral of firms to DOJ for further regulatory action.  Her approach with her clients struggling to achieve a favorable compliance profile with FDA is to be thorough, appropriately risk-based, and fully transparent with FDA, ensuring a continued stream of open communication to FDA on the status of commitments, providing evidence of completion in each communication to FDA.

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    • Why Us
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    • 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

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