Internal Auditing to MDSAP Concepts and Practices in Aligning the Internal Audit Program
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Speaker : MICHAEL C. REDMOND
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When : Tuesday, July 15, 2025
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Time : 01 : 00 PM EST
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Dr. Michael C. Redmond, PhD, a renowned expert in ISO standards and
cybersecurity management. With a career spanning decades, Dr. Redmond
has worked with organizations worldwide to implement robust
cybersecurity policies and frameworks. Her ability to convey complex
technical challenges in actionable ways sets her apart as an industry
thought leader. With her guidance, you will gain the knowledge and tools
needed to address today’s most pressing cyber risks head-on.
The Medical Device Single Audit Program (MDSAP) is a global initiative designed to standardize regulatory audits for medical device manufacturers. Meeting MDSAP requirements is critical for companies seeking to sell their products in participating countries. This session will uncover how internal audits play a pivotal role in ensuring compliance, enabling organizations to improve the quality of their processes and products.
Participants will learn the key principles of MDSAP, how it operates across jurisdictions, and why it’s essential to align internal audit programs with its requirements. We’ll explore how to conduct risk-based auditing, manage findings effectively, and prepare for official audits.
This session will provide practical tools and techniques for aligning your internal audits with MDSAP standards, ensuring that quality management systems meet global regulations. Case studies will offer real-world examples of successful MDSAP preparations, focusing on lessons learned from common pitfalls.
By attending, you will gain the knowledge and confidence to adapt your internal audit processes to the rigorous demands of MDSAP, enhancing your ability to deliver compliant and high-quality medical devices.
Areas Covered
- Overview of MDSAP and its significance for medical device manufacturers
- Key principles and requirements of MDSAP
- Role of internal auditing in MDSAP preparation
- Conducting risk-based internal audits
- Enhancing cross-departmental collaboration for audit success - Aligning internal programs with MDSAP standards
- Building a compliant infrastructure
- Documenting evidence to satisfy audit requirements - Common challenges during MDSAP audits and how to overcome them
- Case studies of organizations successfully aligning with MDSAP
- Effective management of non-conformities discovered during audits
- Establishing an audit-ready culture in your organization
- Upcoming changes and trends in regulatory audits (MDSAP and beyond)
Who Should Attend
- Quality Assurance Managers and Specialists
- Internal Auditors and Audit Managers
- Regulatory Affairs Professionals
- Compliance Officers
- Risk Management Teams
- Medical Device Manufacturers’ Executives and Managers
Why Should You Attend
- Learn how to align your internal audit program with MDSAP requirements to ensure compliance across all jurisdictions.
- Understand the consequences of inadequate auditing practices, including failed audits, financial penalties, and loss of certification.
- Gain insights into strategies to prepare your organization for MDSAP certification, promoting organizational readiness.
- Discover how internal audits can identify and mitigate quality risks before they escalate into regulatory issues.
- FUD liner for marketing purposes: “What happens when your internal audits fall short of MDSAP standards? The costs of non-compliance can be catastrophic. Equip your team with the strategies to ensure audit success.”
Topic Background
- Define MDSAP (Medical Device Single Audit Program) as a comprehensive program designed to streamline regulatory compliance and promote quality in medical device manufacturing across multiple regulatory jurisdictions.
- Highlight the importance of internal auditing in ensuring readiness for MDSAP audits and supporting continuous quality improvement.
- Discuss the growing complexity of regulatory environments in the medical device industry, especially with varying requirements from participating countries (e.g., US FDA, Health Canada, ANVISA).
- Show the connection between robust internal audit programs and successful MDSAP certification, focusing on avoiding product recalls, compliance violations, and quality lapses.
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$160.00
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