Enabling organizations to identify, measure, control and improve

New CAPA System
We assisted a major international pharma company in reengineering their CAPA system. The work involved numerous GAP analysis and working with an internal team to redesign the new system. Extensive training was also involved. When FDA inspected the company they were told by FDA that they had one of the best CAPA systems FDA had seen.

Case Studies: Compliance Master Plan

Wells & Associates 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 Working with the project manager and QA Director we were able to develop a newer version of the document that was more understandable and more detailed.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.

Case Studies: Investigation Analysis and Training

Wells & Associates was contacted by a major international drug/device corporation about their internal investigations. Internal reviews and FDA inspections pointed out weaknesses in that area. Wells & Associates performed a gap analysis by reviewing samples of investigations from divisions across the organization.

Later that year Wells & Associates was asked by the corporation to assist in a major training initiative for conducting investigations. Working with company representatives Wells and Associates 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").

Wells & Associates 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, Wells & Associates performed a second gap analysis of their investigations about six months later. A one year follow-up analysis is also planned.

Case Studies: Post - Warning Letter Intervention

Wells & Associates 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.

Case Studies: CAPA Program Development

Wells & Associates 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. Wells & Associated 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.

Case Studies: Corporate Survey/Gap Analysis

Wells & Associates 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.

Case Studies: FDA Preparation Training

Wells & Associates was contacted by a device company to provide training on FDA Readiness in anticipation of an upcoming inspection. The five day "FDA Inspection Readiness Training" training program was held at the company. Accolades were received from both the site management and the (inspection) logistical personnel.

The training was followed up about a month later by a five day visit which primarily included a four day mock-inspection. Based on the results of the mock-inspection the facility was found to be in a state of readiness for the anticipated inspection.