Developing an FDA/ISO Compliant Quality Management System

This training session focused on developing an FDA and ISO 13485 compliant Quality Management System (QMS) for a medical device company.

• Understand Regulatory Requirements: Develop a foundational understanding of the FDA regulations (21 CFR Part 820) and ISO 13485:2016 standards, including their similarities and differences.
• Identify Core QMS Components: Learn about the essential elements of a compliant QMS, including document control, risk management, design controls, and CAPA.
• Implement the QMS: Gain practical insights into the steps for implementing and integrating a QMS within the organization, ensuring effective documentation and training.
• Address Challenges: Recognize common challenges in achieving compliance and learn strategies to address them effectively.

Overview of FDA and ISO 13485 Requirements
   - Importance of FDA and ISO 13485 Compliance
   - FDA Regulations (21 CFR Part 820)
        - Key Requirements
   - ISO 13485:2016 Standards
         - Key Requirements
- Comparative Overview: FDA vs. ISO 13485
Preforming a Gap Analysis 
Understanding the current company products and processes
Scope and Applicability
-    Determining the applicable Elements of Quality Management System requirements
Implementing the QMS
   - Steps for Effective Implementation
   - Integration with Existing Processes
   - Document Creation and Maintenance
   - Training and Employee Engagement
Common Challenges and Best Practices
 - Identifying Common Pitfalls
   - Effective Strategies for Compliance
Q&A and Wrap-Up
   - Open Floor for Questions and Discussion
   - Summary of Key Takeaways

To become equipped with the knowledge and tools necessary to develop, implement, and maintain a Quality Management System (QMS) that meets FDA and ISO 13485 standards for medical device companies. This training will provide a clear understanding of regulatory requirements, core QMS components, and best practices for compliance.

• Quality Assurance/Quality Control (QA/QC) Managers
• Regulatory Affairs Specialists
• Compliance Officers
• Design and Development Engineers
• Production Managers
• Senior Management

Ms. Marie Dorat, is a hands on Regulatory/Quality Professional with 23 years experience in the Medical Device, Biopharmaceutical/Pharmaceutical industries in various senior positions.  She has a high level of expertise in the regulatory/quality arenas, with an astute knowledge of GCP, cGMP QMS Development, validation, CAPA, NCMR, Change Control, and Training. Ms. Dorat is also a certified Lead Auditor for ISO/IVDR/MDSAP and has published articles for compliance magazines related to Clinical Site Inspections FDA vs. EU; Developing a compliant Quality System to name two.
She has facilitated e-QMS enterprise development, software validations, worked in a Consent Decree environment and supported remediation projects.