Case Studies

Interim Professional Program

Consent Decree Project
For a client under Consent Decree we provided manpower to work within the Quality Organization due to lack of personnel on the client end. These projects were six months to over a year. The positions we filled on a temporary basis were:

  • ‘Acting/Interim’ Quality Manager
  • ‘Acting/Interim’ Complaints Manager
  • ‘Acting/Interim’ CAPA Manager
  • ‘Acting/Interim’ Sustaining Engineering Manager

Quality Manager – Warning Letter Client Project
For a client under a Warning Letter we provided an ‘Acting/Interim’ Quality Manager. This person managed the day-to-day Quality organization as well as managing the efforts to address the Warning Letter and prepare for an FDA reinspection. The duration of the project was over 18 months. For this project the client was so happy with the individual they asked if he could serve as ‘Acting/Interim’ VP of Quality.

Senior Advisor Warning Letter Client Project
For a client under several Warning Letters we provided an individual who provided two specific scopes of work over a 12-month duration:

  • ‘Acting/Interim’ Quality Management System Senior Advisor who served as the corporate-level Project Architect for a company-wide Risk Management program
  • Served as Coach to an incoming Corporate Quality VP

Audit Program Manager
For a Medical Device client we provided an individual who served for over six months as the ‘Acting/Interim’ Internal Audit Program Manager. This individual also performed several audits in numerous countries while serving in this capacity.


Consent Decree Projects

Consent Decree Project (Client A) – Served as 3rd Party Expert (18 month project)

  • Performed Verification Audits of the Client’s Quality Systems
  • Performed In-Depth Reviews of Client’s DHFs, CAPAs, Risk Documentation and all related documents based on Consent Decree requirements (Due to “product issues”)
  • Worked with company management and in-house attorneys on strategy
  • Attended meeting with FDA District Office
  • Worked with the Client’s external FDA attorneys

Consent Decree Project (Client B) – Served as Interim Professionals, Team Leads, Trainers, Coaches and SMEs (2 year project)

  • Performed Audits prior to the Consent Decree
  • Met with FDA (Included local District Management, CDRH, ORA and Attorneys)
  • Provided “Acting/Interim”: Quality Manager, Complaints Manager, CAPA Manager, Sustaining Engineering Manager
  • Provided Remediation Team Leads and SMEs: Corrections & Removals, Computer System Validation, Management Controls, Internal Audit, Risk Management and Design Controls, CAPA, and other areas as needed
  • Provided FDA Compliance Training to senior management
  • Worked with company management and in-house attorneys on strategy
  • Worked with the Client’s external FDA attorneys
  • Managed the back-room during Certification Audits and FDA Inspections

*Note: Certification done by another consulting company.


Warning Letter Projects

Recidivist Warning Letters Projects (Several Clients; Project duration varied from 18 to 36 months)

• Served as 3rd Party Expert per the Warning Letter

  • Audited numerous sites several times for each client (baseline audits, mid-point audits and post remediation audits)
  • Provided Strategic Consulting as needed (Each project is different!)
  • Provided some training and targeted consulting advice to work streams

Corporate-Wide Warning Letter Project (24+ month project)

• Served as 3rd Party Expert per the Corporate Warning Letter
• Performed a comprehensive Management Controls Assessment (Interviewed all senior staff and compiled a detailed report)

  • Met several times with FDA District Office, CDRH and Office of Enforcement
  • Audited 20+ sites and HQ twice for Compliance (baseline and post remediation)
  • Provided strategic consulting assistance with Compliance Master Plan, and reviewed and commented on work being done by the work streams
  • Trained 20+ sites and HQ on FDA Readiness and trained Senior Management

• Worked with company senior management on strategy
• Worked with the Client’s external FDA attorneys
• Provided extensive training to senior management and to all sites
• Provided coaching and site FDA inspection preparation training

Warning Letter Project (14 Month Project)

  • Served as Project Architect
  • Created & managed Compliance Master Plan
  • Provided Subject Master Experts for CMP work streams
  • Provided Associate (“worker”) level consultants to support work streams and day-to-day business operations
  • Total Quality System Rebuild
  • Provided FDA Readiness support including coaching and content development

Multi-Site Warning Letter (18+ month project)

  • Performed Quality System baseline audits (17 domestic & international sites) including detailed reports and project management services, cGMP audits, Clinical audit, and Good Laboratory Practices audit
  • QualityHub consultants served as workstream SMEs on specific subsystems for client for an extended period of time following audit series
  • Provided ‘Acting/Interim’ Quality Management System advisor who served as the corporate-level Project Architect for a company-wide remediation program
  • Provided Associate Consultant supporting the Risk Management system rebuild


Quality System Optimization Projects

New CAPA System
We assisted a major international pharma and medical device company in reengineering their corporate-wide CAPA system. The work involved numerous GAP analysis and working with an internal team to redesign the new CAPA system. Extensive training was performed which included “train-the-trainer” to ensure that 40,000 employees worldwide could understand and use the new CAPA system.

To determine if the program was successful, we performed an additional gap analysis of their CAPAs across all regions and business segments of the company for two years, following deployment of the new CAPA system. These gap analyses showed great improvements over time.

Note: When FDA later inspected the company, they told the company they had one of the best CAPA systems FDA had seen.

Compliance Master Plan
QualityHub assisted an international device company with their existing compliance master plan. Working with the project manager and QA Director we were able to develop a newer version of the document that was more understandable and more detailed. Using our ex-FDA expertise we determined more emphasis was needed on accountability and responsibilities. We were able to improve the document to more closely hold persons responsible. We also guided the company to use measurable data for the milestones, thus focusing on the metrics that were needed to demonstrate the success of the milestones via objective evidence. Since numerous project teams were involved in implementation, we worked with the project manager, who held the project team leaders responsible for providing key details in the document. Based on our guidance and requirements the teams provided us with improved responsibilities information and information on the objective evidence they would use to demonstrate accomplishment of the milestones.

Investigation Analysis and Training
QualityHub worked with a major international drug/device corporation to help improve their internal investigation processes and skills. Internal reviews and FDA inspections pointed out weaknesses in that area. We performed a gap analysis by reviewing samples of investigations from divisions across the organization.

Working with company representatives, QualityHub developed a full day training program on conducting investigations. The course materials were licensed to several thousand users, who became the corporation’s trainers worldwide (using “train-the-trainers”).

QualityHub participated in training the first two levels of trainers and certified the initial cadre. The company trainers presented the training to sites worldwide and initiated other improvements in their investigation programs

To determine if the program was successful, we performed a second gap analysis of their investigations about six months later and at one year post deployment. These gap analyses showed great improvements.

Warning Letter Intervention
QualityHub was contacted a strategic consulting partner to assist with a drug manufacturer who had recently received an FDA Warning Letter. Working with the partner company we assisted in developing the overall compliance plan and writing the FDA update submissions. The compliance plan included major improvements in the validation program, investigations/CAPA, change control, and management controls. Utilizing several specialized contractor consultants and company personnel we were able to implement a new quality system – and work on culture change initiatives – to ready the company for the inevitable FDA inspection.

CAPA Program Development
QualityHub was contacted by a drug company to assist in the development of a new CAPA program. Working with the company we reviewed their current program and guided them in the development of a new CAPA program. QualityHub also briefed local management and provided training to all applicable personnel on the new system. We also provided some guidance on the role of automation systems for their CAPA information.

Corporate Survey/Gap Analysis- Complaint Handling
QualityHub was contacted by a drug/device company to provide the main office with an analysis of practices company-wide. We visited numerous sites in Europe and the US and provided a report of our findings. Process maps were developed and information was gathered on strengths and weaknesses of the program. This information will be used for future process improvements as well as organizational analysis.

Corporate Survey/Gap Analysis – Complaint Handling and MDR
QualityHub was contacted by a major international device company to perform an analysis of Complaint Handling practices company-wide and world-wide. We visited over 20 sites to gather information about their complaint handling and MDR practices. The analysis included extensive sampling of complaints – non-MDR reported and MDR reported. The project included an extensive data gathering activity using pre-planned sampling plans, questions and analysis tools. Reports were prepared which the company used to improve their complaint and MDR practices worldwide. We also consulted on their new and improved complaint and MDR procedures.

FDA Preparation Training
QualityHub helped numerous medical device companies in the US, Asia and Europe, prepare and handle FDA inspections. Overwhelmingly, the clients reported that our assistance was very helpful in handling the FDA Inspections, and also in minimizing the number of FDA-483s the sites received from FDA at the conclusion of the inspections. The reduction of FDA-483s resulted in no Warning Letters for nearly all of these companies.

FDA Inspection Preparation and Back-Room support
We helped a European company plan for and handle an FDA inspection. This included pre-inspection gap assessments, SME interviews and SME training, as well as management training and site preparation for the inspection. During the actual inspection we helped the back room in orchestrating the documents and SMEs that presented during the inspection. The company passed the inspection with flying colors.


Compliance Remediation

Compliance Remediation Project
For a medical device implant manufacturer, we provided a full quality system rebuild and remediation. The front-end of this project included baseline audits of their manufacturing sites in US and Europe. Based on gaps identified by FDA and the QualityHub audits, we created a Compliance Master Plan (CMP) that guided the project. The CMP included interim controls, future state (a rebuilt quality system), and remediation activities. In parallel to the CMP work, we created FDA-483 proof books and coached the company on handling the next FDA inspection. QualityHub brought in a Project Leader, Project Managers, Executive Coach, ex-FDA Mock Investigators, Team Subject Matter Experts (SMEs), and numerous Associate-level consultants to assist with the day-to-day work at the company as well as the remediation work. The company passed their next FDA inspection. The project lasted fourteen months.


Compliance Remediation Project
For a medical device manufacturer with many sites worldwide, QualityHub was hired after they received a 2nd Warning Letter. We helped with the creation of a Compliance Master Plan (CMP). We provided Subject Matter Experts (SMEs) to work with company workstream owners and guided the creation of new processes, procedures, and the remediation of various quality system records such as Complaints, MDRs, CAPAs and Device History Records. We also provided audits at sites worldwide. Finally, we helped sites worldwide prepare for their FDA inspections.

Regulatory Strategy

Regulatory Strategy Project
QualityHub worked with one major medical device company before, during, and after a Consent Decree. Working with their in-house and external attorneys, we helped develop strategies to address FDA’s concerns, stabilize their quality system, and develop the necessary improvements to the organization and the quality system. During this project we also were able to provide Interim Professionals to assist with several positions in the company.

The work involved planning for and attending meetings with FDA, assisting in the formal written responses to FDA, and creating the overall plan/strategy that FDA was expecting to see. Execution of the plan followed on this project – which lasted close to two years. We worked closely with the company’s senior management, in-house, and external attorneys throughout the project. For this project, QualityHub was not the certification auditor, but rather the organization helping the company rebuild and reshape their quality system.

Regulatory Strategy Project
For a major medical device company, we assisted in their handling of a Recidivist Warning Letter. In this case, we helped the organization understand FDA’s logic behind the Recidivist Warning Letter, and assisted in the negotiations with FDA in terms of scoping the number of sites that needed certification audits, and the overall process for the certification audits to occur. FDA approved the plan. We subsequently worked with the company over three years, performing Certification Audits at four sites as needed. Several rounds of audits were performed, and each round demonstrated continued improvements in the company’s quality system and overall compliance. The conclusion of the project was the completion of the final audits, showing a greatly improved organization, and the reporting of the audit results to FDA.



Auditing Project
For a major medical device manufacturer under a Warning Letter, QualityHub provided over 20 before-and-after Quality System audits of the client’s manufacturing sites in the US and Europe. These audits allowed the company to gauge whether their quality system rebuild and remediation activities were successful. The project also involved a third visit to each of the sites to prepare them for FDA inspections.

Auditing Project
QualityHub visited close to 20 sites in the US, Mexico, Canada and Europe for a major medical device company under several Warning Letters. While most of the audits were against 21CFR820, the Medical Device Quality System Regulation, some of the sites were also audited to the Drug GMP 21 CFR210/211 regulations.

Auditing Project
QualityHub performed “corporate” internal audits for several of the more difficult sites for a major international medical device company. For these successful audits, QualityHub provided veteran auditors with experience handling complex and difficult situations. We continue to provide support to this and several other companies in order to assist in the execution of their complex internal audit programs.