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Case Study:

Medical Device/Pharmacovigilance

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Client:

Large company based in the Chicago area that specializes in injectable drugs and infusion technology.

Key Issues:

Our client was having many QA and Product Safety issues. They needed to identify their internal safety violations, implement a plan to identify and correct the compliance issues, and subsequently train Product Safety Department personnel.

Solution:

A CAPA (Corrective And Preventative Action Plan) was put into place for the Global Product Safety Department. Consultants (Project Managers, Safety Physicians, Drug and Device Safety Associates) were deployed and added to various teams within Safety in order to ensure all product safety-related issues were properly addressed, corrected and managed per regulatory guidelines.

Overall project consisted of 3 different team responsibilities:

      • CAPA Project Management consulting efforts to lead overall CAPA team in compilation, production and oversight of health authority inspection proof books and inspection readiness. Managed Cross functional teams between US, UK and Manila.
      • Safety Operations consulting utilized to manage day to day operations including complaints, vigilance reporting and metrics (per regulatory standards). This team was utilized in two ways; to provide day to day operations support and to develop and administer

      • Drug Safety consulting utilized to develop and implement a Safety Integration Plan and team. These were successfully put into place based on subsequent merger that was announced well into the CAPA project between two organizations (client was acquired mid way thru project).

Conclusion:

BioPoint’s team helped our client’s Global Product Safety group align with regulatory standards. This was done through successful management of Safety CAPAs, and the implementation of a team that effectively worked on a daily basis to:

      • Process cases and reports according to regulatory standards, and,
      • Bridge the gap between two merging Product/Drug safety departments.