Fundamentals of Medical Device Awareness Single Audit Program (MDSAP) Training by Tonex
This comprehensive course, “Fundamentals of Medical Device Awareness Single Audit Program (MDSAP) Training” by Tonex, equips participants with a deep understanding of the MDSAP framework. Designed for professionals in the medical device industry, this training ensures compliance and proficiency in navigating the intricacies of MDSAP audits.
Tonex presents an essential “Fundamentals of Medical Device Awareness Single Audit Program (MDSAP) Training” designed for medical device professionals. This comprehensive program, spanning crucial modules, delves into the intricacies of MDSAP compliance. Participants gain insights into the MDSAP framework, audit processes, and global regulatory requirements.
The course emphasizes risk management, quality management system integration, and adept documentation and reporting practices. Tailored for regulatory affairs specialists, quality assurance professionals, and auditors, this training ensures a nuanced understanding of MDSAP, fostering competence in navigating its complexities. Elevate your expertise and fortify your organization’s compliance with this indispensable training from Tonex.
Learning Objectives:
- Grasp the foundational concepts of the MDSAP framework
- Understand the key elements of a successful MDSAP audit
- Learn to implement best practices for compliance with global regulatory requirements
- Gain insights into risk management and quality management system (QMS) integration
- Acquire proficiency in documentation and reporting for MDSAP audits
- Develop strategies for continuous improvement in MDSAP compliance
Audience: This course is tailored for professionals in the medical device industry, including regulatory affairs specialists, quality assurance professionals, auditors, and those involved in ensuring compliance with global regulatory standards.
Course Outline:
Module 1: Introduction to MDSAP
- MDSAP Framework Overview
- Evolution of MDSAP in the Medical Device Industry
- Key Components of MDSAP
- Purpose and Objectives of MDSAP Audits
- Benefits of MDSAP Compliance
- Case Studies on Successful MDSAP Implementation
Module 2: MDSAP Audit Process
- Stages of an MDSAP Audit
- Audit Planning: Preparation and Scope Definition
- Onsite Audit Execution
- Audit Reporting and Findings
- Non-Conformities and Corrective Actions
- Post-Audit Follow-Up and Continuous Improvement
Module 3: Global Regulatory Requirements
- FDA Regulatory Standards
- Health Canada Regulations
- European Union Medical Device Regulation (MDR)
- Australian Therapeutic Goods Administration (TGA) Requirements
- Japanese Pharmaceuticals and Medical Devices Agency (PMDA) Guidelines
- Harmonization of Global Regulatory Standards
Module 4: Risk Management in MDSAP
- Integrating Risk Management into MDSAP
- Risk Assessment Methods and Tools
- Risk Mitigation Strategies
- Monitoring and Updating Risk Management Plans
- Aligning Risk Management with Quality Objectives
- Case Studies on Effective Risk Management in MDSAP
Module 5: Quality Management System Integration
- Establishing a Robust Quality Management System (QMS)
- Integration of QMS with MDSAP Requirements
- QMS Documentation and Record Keeping
- Training and Competency Development in QMS
- Auditing the QMS for MDSAP Compliance
- Continual Improvement in QMS and MDSAP Integration
Module 6: Documentation and Reporting
- Best Practices for Documentation in MDSAP
- Document Control and Versioning
- Recordkeeping Requirements
- Developing Comprehensive Audit Reports
- Communicating Findings to Stakeholders
- Ensuring Compliance with Documented Procedures