Strategies to Meet FDA Regulatory Compliance

A Two-Day Comprehensive & Interactive Course with Workshops on:

- FDA's Center for Devices and Radiological
Health Investigations
- Clarifying FDA Classification of Medical
Devices
- Memoranda of Understanding (MOU)
- Developing QSR/GMP/ISO for combo products
- Principals of ICH GCP for Medical Devices
- Definitions and Classifications of Medical
Device
- The Premarket Notification (510K) Summaries
and Reviews
- Investigational Device Exemption (IDE)
Applications
- Premarket Approval (PMA) Review Process
- Safety and Effectiveness Requirements
- Humanitarian Device Exemption (HDE)
- Post Market Obligations
- Managing Recalls and Problem Reporting
- Planning and Implementing an Clinical Audit
- Determining a Regulatory Strategy
- Clinical Trials for Medical Devices
- Sponsor Obligations
- Inspection and Audit of Vendors
- FDA Notification procedures

Who should attend? This two day course and workshops series program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in the Medical Device, Combination Products, Biotechnology - Medical Devices - Product Submission - Regulatory Affairs - Quality Assurance - Quality Control - Clinical Trials - Product Development - GMP Compliance - Internal & External Auditing - Research and Development - Manufacturing - Engineering - Validation - Training - Documentation - Consultants - Sales, Marketing, Distribution - Legal