Modernizing Internal Audit Processes to Better Support Business Success
Friday, Feb 7, 2025
8:00am - 10:30am
Coffee and breakfast at 8:00 AM,
followed by the presentation starting at 8:30 AM.
In-Person
8900 Keystone Crossing
Indianapolis, IN 46240
About the Event
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.
This in-person session in Indianapolis, IN, is designed for life sciences, pharma, medical device, and FDA-regulated companies seeking to enhance audits and ensure compliance.
Our speaker, Mike Wolf, Director of Client Services at Theoris, brings 20+ years of experience guiding organizations—big and small—through internal audits, supplier audits, and FDA readiness, offering invaluable insights into best practices. He will be covering the following topics:
- 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.
Reserve Your Spot!
We’re sorry to share that Modernizing Internal Audit Processes to Better Support Business Success, originally scheduled for February 7, 2025, will no longer be taking place.
We appreciate your interest and hope to see you at a future event.
Meet the Presenter
Mike Wolf, CMDA, CQA, RAC
Director of Client Services at Theoris
Mike Wolf, CMDA, CQA, RAC, 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).