Medical Device Approvals Process

Venue: Toronto, Canada

Location: Toronto, Ontario, Canada

Event Date/Time: Mar 03, 2008 End Date/Time: Mar 04, 2008
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Description

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

Venue

Additional Information

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

Types