You roll over, adjust the pillows, get up for a drink of water, but you still cannot shake that weird feeling about your company’s interim staffing needs?
Have I thought of all the options? Is there something I’m missing? What’s gonna happen if I pull Ron off his current work and have him jump in on the new project?
Managing over-worked staff and filling gaps in expert and executive positions has become increasingly difficult. But talent gaps do not need to be scary. If you’re in need of interim expert and executive staff augmentation, let Compliance Architects® help you assure the continuity of your regulatory, quality and compliance operations.
You Run Your Business.
We Find You Interim Experts and Executives!
Since 2009 Compliance Architects® has been building relationships with the industry’s top independent experts and executives. If you’re in need of additional experts or executives to augment your current staff, we’re here to help.
Whether you need a CAPA expert for a three-month assignment to work through a backlog or a senior-level executive to help temporarily lead your quality assurance team, Compliance Architects® can deliver an extensive global team of specialists and expert resources to support you.
We’re more than just a “body shop” or a “temp agency.” Our database of specialists and experienced executives is the deepest in the industry. Plus, our talent are proven executives that have “been there and done that” at companies large and small.
How do we do it? Our strength in successful interim expert and executive placements is anchored by our database of more than 400 professionals. Each expert or executive we affiliate with goes through an extensive skills assessment to assure they’re the best at what they do.
We also check beyond what’s on paper. We dive deep, considering other variables such as personality, work history, communication style, and whatever else would help with the assignment. Our mission is to deliver the best-aligned expert consultants for FDA-regulated companies.
No project is too big, complex or unique.
CASE STUDIES — Recent Interim Placements:
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.