The Background
A mid-sized pharmaceutical manufacturer with a diverse product portfolio faced challenges with PDMA compliance, and the efficiency of their representative hand carry program. Since the hand carry program’s inception, changes in staffing, and vendors had occurred, prompting the client to recognize the need for a thorough review of its documentation and processes. Additionally, the client sought to incorporate industry best practices to enhance the program’s efficiency, and cost-effectiveness.
The Challenge
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- Program Evaluation: The client’s longstanding program required a thorough review, with established internal policies, and procedures needing actual process audits to ensure effectiveness.
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- High Volume of FDA Reportable Events: The client experienced a high volume of significant losses during the sample reconciliation process. A need for a more structured reconciliation process was identified.
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Your Challenge
The Story
This manufacturer needed a more robust and strategic approach to ensure compliance of their representative hand-carry program.
QPharma’s Solution
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- Expertise Deployment: QPharma leverages its recognized industry leadership in sampling compliance, and representative hand carry programs, employing subject matter experts to guide the project.
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- Program Implementation: Initiated with a kick-off meeting to define scope and timelines, followed by thorough documentation collection, stakeholder interviews, and weekly status updates to ensure alignment, and address emerging issues.
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- Proactive Monitoring and Field Support: A daily review of transactional activities was conducted, identifying potential discrepancies or variances that could negatively impact the sample reconciliation process. Field support was provided on best practices and error mitigation.
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- Sample Reconciliation Analysis and Support: An analysis of each significant loss is conducted, and mitigation support is provided. Client data is leveraged to assist in sample reconciliation.
Titanium Results
The client experienced a substantial reduction in significant losses and FDA reportable events. Transactional errors decreased and reportable events were identified proactively, resulting in fewer inventory discrepancies. The overall customer experience greatly improved.