Modernizing Internal Audit Processes to Better Support Business Success

Join us for a focused session on modern internal auditing practices that enhance business outcomes, ensure compliance, and drive operational success. Learn practical strategies for building high-performing teams, gaining leadership buy-in, and integrating audits with risk management frameworks.

Our speaker, Mike Wolf (CMDA, CQA, RAC), brings 20+ years of experience guiding organizations—big and small—through internal audits, supplier audits, and FDA readiness, offering invaluable insights into best practices.

• Getting Ownership and Buy-In: Secure leadership support and align audits with business goals.
• Building and Broadening the Audit Team: Develop a capable, dynamic team for evolving business needs.
• Providing Effective Training – With Real Practice Audits: Train auditors with hands-on, real-world scenarios.
• Maximizing Effectiveness – CAPA and Risk Management Links: Strengthen operations through audit integration with CAPA and risk management.
• Flipping the Switch – Outsourcing the Internal Audit Process: Weigh the benefits and challenges of outsourcing audits.

Mike Wolf, Director of Client Services at Theoris, is a seasoned professional with a solid record of accomplishment in Regulatory Affairs and Quality Management Systems with companies in the life sciences. In his roles in industry and as a consultant, he has helped organizations develop the knowledge, skills, systems, and processes necessary to achieve and maintain compliance with national and international standards and regulations in support of business success and growth.

Mr. Wolf has over twenty years of experience in designing, documenting, implementing, and improving the auditing systems of companies as small as start-ups and as large and complex as multi-nationals. His experience includes internal audits, supplier audits, and gap assessments in preparation for FDA inspections and certification audits by external bodies.

Mr. Wolf is a Certified Medical Device Auditor (CMDA) and Certified Quality Auditor (CQA), and has the Regulatory Affairs Certificate (RAC). Connect with Mike on LinkedIn.

Event Venue & Nearby Stays

Theoris, 9000 Keystone Crossing, Indianapolis, United States