There are many things the FDA-regulated industry—including medical device manufacturers and professionals—should know about the FDA’s current inspection policy to adequately implement the good manufacturing practices (GMPs). The consequences of failing to comply with FDA regulations can lead to such severe civil and criminal actions, that you simply can’t afford to take them lightly.
Learn the nuts and bolts of establishing GMPs for medical devices in this session by regulatory expert David Lim. Lim will discuss the critical factors you should consider when establishing design control. He will walk you through the common mistakes companies make, and show you how to avoid them. He will also be providing practical, actionable, sustainable solutions in an integrated, thorough manner (PASS-IT).
After attending this session, you will be better equipped to comply with FDA’s new inspection policy and trends. You will know how to identify the important factors when implementing GMPs for your medical devices—including the critical factors for design control. Plus, you will be confident in your ability to avoid the common mistakes companies often make, thereby minimizing the risk of civil or criminal liability.
- Identifying and understanding important factors when establishing good manufacturing practices for medical devices
- Identifying and understanding critical factors to consider for design control
- Recognizing, understanding, and avoiding common mistakes
- R&D scientists, engineers, managers, and directors
- Regulatory affairs professionals
- Quality professionals
- Product development professionals
- Contract research organizations
- Contract manufacturers
- Management representatives
- Contractors and subcontractors