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.
