Auditing for Risk in the World of Regulatory Compliance
IVT Conference: Session 20 Advanced
Len Grunbaum, Partner, Practical Solutions Group
Nancy Wyant, Senior Clinical Project Manager, EMD Serono, Inc.
“Providing a regulatory observation without the business context is like serving coffee without a cup.” SM This observation provides the premise for this workshop: that there is business benefit to be gained from regulatory audits and that auditors, auditees and managers should know about and strive to attain. The objective of this workshop is to provide the business context and value of auditing for risk, as opposed to a “one-size-fits-all” approach, in the world of regulatory compliance.
I. How to Audit for Risk
- Gain insight into why and how audits should be performed to maximize business value
- Learn the difference between types of audits (e.g., due diligence, investigations) and when they should be performed
- Learn the relationship between regulatory issues and underlying operational problems
- Learn how to present findings and recommendations to maximize business value
II. Value to Management of the “Risk-Based” Auditing Approach
- As management, learn about business need in commissioning an audit; i.e., what management should expect from an audit
- Understand the value of the business context of regulatory observations
- Learn what types of findings and recommendations bring the most value
- Learn what management should respect in an audit/auditor
III. Case Studies
- Discuss several actual cases and apply the principles identified above
IV. Interactive Workshop
- The interactive workshop will provide an opportunity for the attendees to analyze business/regulatory scenarios and identify regulatory issues and underlying operational problems. The instructors will provide the scenarios and break the attendees into groups of four – five. The attendees will identify regulatory issues and underlying business problems, and develop a bullet-point report of findings and recommendations to present to the group as a whole.
Who Should Attend
- Quality Assurance Managers
- Quality Assurance Staff
- Consultants who perform external audits
- Individuals responsible for groups/departments that are frequently audited