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Compliance Architects

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Interim Expert & Executive Placement for Life Sciences Companies

Global drug/device combination products manufacturer — When one of our clients struggled with enough talent to fulfill a broad remediation plan they promised the FDA, they turned to Compliance Architects®.  After quickly scoping their needs and factoring in the company’s “personality” we were able to select the perfect individual to work hand-in-hand with their staff.  In short order our colleague provided the following:

  • Represented their needs, requirements, and objectives in the workstreams for deviation management, CAPA and change control.
  • Reviewed and provided invaluable feedback on workstream outputs, including standard operating procedures, metrics, and their training material.
  • Provided updates to program leadership regarding the delivery plans and schedule for these workstreams and helped program leadership evaluate how well requirements and objectives were being met.
  • Supported executive leadership with establishing and maintaining appropriate governance forums (e.g., CAPA Review Board), and supporting activities related to these forums

Fast growing biotech — Migrating to a new software system is always a tough project.  Get it right and you’re a hero.  Make a mistake and you’re deemed a failure. Through a referral, Compliance Architects® was introduced to a new client that desperately needed a change management AND communications executive.  That’s not an easy person to find and place on a project.  But after a detailed needs analysis, Compliance Architects® was able to find just the right person to lead this Trackwise project to success.  In a matter of months, our consultant:

  • Developed and managed communications plans, content and materials and distributed communications to business partners.
  • Worked through change management opportunities, benefits analysis and supported key users/stakeholders through significant changes.
  • Developed materials for Project Go-Live and the boots-on-the ground implementation of the programs.
  • Provided support in creating and updating communications content and organizing in SharePoint, Microsoft Teams.

Pharmaceutical manufacturer — Having a significant backlog of CAPAs across 3 manufacturing sites and the home office is a huge red flag for the FDA.  But that’s what a client had when they called us and asked for help.  Tapping into out talent database, Compliance Architects® was able to quickly pull together a CAPA support squad to help this client get back track.  Our experts made sure to:

  • Drive individual CAPAs to completion at each of the three manufacturing sites and home office.
  • Rationalize CAPAs that were initiated against other structured, documented programs, to identify and correct redundancies.
  • Assist individuals and teams to get CAPAs driven to completion, and to help bring the numbers of open CAPAs to acceptable levels going forward.
  • Coordinated training scheduling, program meetings to assure long term operational success.

Global pharmaceutical manufacturer — Nothing can get out of hand faster than non-conformances and poor root cause analysis/failure investigations.  Knowing they had serious problems, Compliance Architects® was retained by a global pharmaceutical manufacturer to provide a team of experts to temporarily help support projects at multiple sites to improve their investigation and documentation of non-conformances.  Our team was ready to go quickly and before you knew it delivered:

  • Subject matter and process expertise with the identification, evaluation, investigation, documentation, and resolution of non-conformances in manufacturing, packaging, maintenance, warehousing.
  • Investigation of assigned non-conformance events and accurately documented the event, investigation, and root cause(s) in the investigation report.
  • With direction from the respective site quality leads, worked directly with site personnel on efforts relating to the reduction of existing NC backlogs at each site.
  • Mentored operations and QA regarding investigation approaches, techniques, documentation requirements, FDA requirements and expectations and industry best practices.
  • “Pre-reviewed” assigned non conformances and identified further information and analysis needed to progress the document to an “approval-ready” state.
  • Identified, analyzed and risk characterized any observed issues, problems or deficiencies with individual non-conformances and/or non-conformance processes.

Primary Sidebar

Case Study

  • Client References
    IEEP - Interim Expert & Executive Placement
  • Product Classes Manufactured
    FDA Executive Placement, IEEP
  • Number of Employees
    50 - 50,000
  • Number of Client Sites
    Across the Globe
  • Operating Scope
    Interim Executive Placement

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Compliance Architects®

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

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  • 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
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • 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®
    • IEEP
    • REMS
  • 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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  • Writing for Compliance®
  • Quality Pulse®
  • CRPN Quality Roadmap®

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