CIS Discusses How to Identify Noncompliance and Prevent Overpayments at Internal Audit Summit
CIS' Tim Krzeminski, Director, Audit and Risk Assurance, and Madeline Heck, Project Manager, Audit and Risk Assurance, will speak at the 4th Annual Pharma/Biotech/Device Internal Audit Summit.
- Philadelphia, PA-NJ (1888PressRelease) September 25, 2013 - Compliance Implementation Services (CIS), a leading life sciences consulting firm, today announced that Tim Krzeminski, Director, Audit and Risk Assurance, and Madeline Heck, Project Manager, Audit and Risk Assurance, will speak at the 4th Annual Pharma/Biotech/Device Internal Audit Summit, taking place in Philadelphia on September 26-27. They will present the case study, "Proactive Auditing to Ensure CRO Corporate Compliance and Contract Adherence" at 1:45pm on September 26. Krzeminski will also lead the panel discussion "Coordinate Auditing with Compliance Monitoring Efforts" at 11:00am on September 26.
"As sponsors and CROs undergo more scrutiny of their outsourcing relationships, it has become best practice for manufacturers to include a focused evaluation of their CROs in their annual risk assessment and audit plan. In working with manufacturers to conduct these audits, we have identified areas where policies and procedures must be improved, resolved issues of noncompliance with vendor contract terms and uncovered substantial overpayments to investigators and third-party vendors used by CROs," said Krzeminski. "We are pleased to share our experiences with the audit professionals at this conference to help them build audit programs targeting their third-party compliance and contracting vulnerabilities."
During a webinar leading up to the conference, CIS found that approximately 50% of the audience had performed an audit of their CRO outside of the Quality Assurance function, but that half of those surveyed had not conducted the audit within the last two years. Respondents' most critical concerns were noncompliance with FDA and EMA regulations and inadequate third-party vendor due diligence and evaluation.
Conference attendees will receive a CIS educational paper entitled, "A Proactive Approach to CRO Management Ensures Compliance and Mitigates Risk," that addresses the challenges of continually monitoring compliance in a landscape where regulations change often, both locally and globally. The paper examines four key areas that will support stronger transparency and better risk management for both sponsor and vendor.
About Compliance Implementation Services (CIS)
Compliance Implementation Services (CIS) is a consulting firm focused on helping life sciences clients proactively manage complex compliance requirements. We offer a broad portfolio of services and solutions that expand deep into the clinical, manufacturing and commercial disciplines and that align with our clients' strategic priorities and business operations. CIS continually provides leadership, global regulatory knowledge, industry experience and a problem-solving culture that responds to today's compliance and commercial challenges. For more information, visit www.cis-partners.com
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