• +1(847) 967-6000
  • Resources
  • Blog
  • News
  • Events
  • Careers
Metrics: The Balance of Performance & ComplianceMetrics: The Balance of Performance & ComplianceMetrics: The Balance of Performance & ComplianceMetrics: The Balance of Performance & Compliance
  • About Us
    • About Regis
    • Our Team
    • Facility Tour
    • Manufacturing Facility Details
    • Our Distributors
  • Custom API
    • CUSTOM API DEVELOPMENT
      • Analytical Development
      • Process Chemistry
    • cGMP MANUFACTURING
      • CGMP Scale Up
      • Clinical Trial Material
      • Commercial API
      • Custom API Manufacturing
      • HPAPI Manufacturing
    • DEVELOPMENT AND MANUFACTURING SUPPORT
      • Fate and Purge
      • Impurity Services
      • IND Enabling Supply
      • Milling
      • Project Management
      • Quality Assurance
      • Quality Control
      • Solid State Chemistry
      • Stability Services
  • Chromatography Products
    • CHROMATOGRAPHY COLUMNS
      • Chiral HPLC & SFC Columns
      • Achiral HPLC & SFC Columns
      • Reversed-Phase HPLC Columns
      • Immobilized Artificial
        Membrane (IAM) Chromatography
      • Free Chiral Screening Service
    • SPECIALTY REAGENTS
      • Ion Pairing Reagents
      • Derivatizing Reagents
  • IMAGING REAGENTS
    • Coelenterazine
    • Luciferin
    • 4-Chloro-1-Naphthol
  • Contact Us
  • ABOUT US
    • About Regis
    • Our Team
    • Facility Tour
    • Manufacturing Facility Details
    • Our Distributors
  • CUSTOM API
    • CUSTOM API DEVELOPMENT
      • Analytical Development
      • Process Chemistry
    • cGMP MANUFACTURING
      • CGMP Scale Up
      • Clinical Trial Material
      • Commercial API
      • Custom API Manufacturing
      • HPAPI Manufacturing
    • DEVELOPMENT AND MANUFACTURING SUPPORT
      • Fate and Purge
      • Impurity Services
      • IND Enabling Supply
      • Milling
      • Project Management
      • Quality Assurance
      • Quality Control
      • Solid State Chemistry
      • Stability Services
  • CHROMATOGRAPHY PRODUCTS
    • Chromatography Columns
      • Chiral HPLC & SFC Columns
      • Achiral SFC Columns
      • Reversed-Phase HPLC Columns
      • Immobilized Artificial Membrane (IAM) Chromatography
    • Specialty Reagents
      • Ion Pairing Reagents
      • Derivatizing Reagents
  • IMAGING REAGENTS
    • Coelenterazine
    • Luciferin
  • CONTACT US
  • News
  • Blog
  • Resources
  • Events
  • Careers
0

Metrics: The Balance of Performance & Compliance

April 3, 2020

Jason J. Orloff presents "Metrics: The Balance of Performance & Compliance."

Wave after wave of quality initiatives have come from other industries and failed to take root. This could be because Pharmaceutical Quality Culture is unlike any other industrial culture. Certainly our risk profile of medium volumes, high costs, and high risks are radically different from the high volumes, low risk, low costs of cell phones, cars, and computer chips. Pharmaceutical Quality Culture is a dynamic, self-correcting system that represents both compliance and performance. A maximally efficient, agile, flexible, pharmaceutical manufacturing sector could be achieved with minimal regulatory oversight by formalizing the systems of performance and ensuring that the balance of compliance and performance is maintained. Process capability measured in %OOS is one such metric where compliance with specifications is weighed against the performance of the process. But where does process capability itself belong: As a compliance reportable? Or as a self-audit of performance done by manufacturing for senior management to prioritize continuous improvement?

Select a video from the collection below:

Metrics: The Balance of Performance & Compliance Part I: Introduction

Metrics: The Balance of Performance & Compliance Part II: Quality in Pharma

Metrics: The Balance of Performance & Compliance Part III: Process Capability

Metrics: The Balance of Performance & Compliance Part IV: Continuous Improvement

Metrics: The Balance of Performance & Compliance Part V: Continuous Improvement

Metrics: The Balance of Performance & Compliance Part VI: Conclusions & Discussion

Share

Information

  • Terms & Conditions
  • Site Map
  • Return Policy
  • Privacy Policy

About Us

  • About Regis
  • Services
  • Products
  • Upcoming Events

Contact Us

8210 Austin Ave
Morton Grove, IL 60053

+1(847) 967-6000
sales@registech.com

Find a Distributor

E-Mail Sign Up











     

     

    Website Created by Advanta Advertising, LLC.
    © 2025 Regis Technologies Inc. All Rights Reserved
    Contact Us
      0
      • Resources
      • Blog
      • News
      • Events
      • Careers

      [ Placeholder content for popup link ] WordPress Download Manager - Best Download Management Plugin

      The Regis Technologies Website is set to allow the use of cookies. Cookies help us to give you the best experience on our website. By clicking Accept or continuing to use the site, you agree to use our cookies. If you decline we will not track your information but your browsing experience might be limited. Please visit our Terms & Conditions and our Privacy Policy for more information.AcceptDecline