This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.
Why Should You Attend:
The last year has seen several major "names" in drugs and devices stumble over cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution. Other recent drug recalls are resulting in several class action lawsuits. A growing push by the Agency to get tougher and strengthen enforcement is one result. Bad publicity affecting once stellar names in the regulated industry is another. Public outcry for a more proactive FDA is yet another. Current FDA oversight methods are claimed to not be providing the product safety or efficacy seemingly promised. What has led to this situation? What can companies do proactively to address these concerns and better ensure better regulatory compliance?
Areas Covered in the Seminar:
- The "tougher" U. S. FDA.
- Recent news headlines - prominent / respected company failures.
- What's behind the headlines.
- The "Heavy Hitters" problem areas.
- Reviewing a company's compliance to these findings.
- Correcting problem-prone areas.
- Entropy - a major "player".
Who Will Benefit:
- Senior management
- Regulatory affairs
- Quality Assurance
- Engineering & R&D
- All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, having to evaluate those changes to existing FDA-cleared 510(K)'s, and then document their decisions in harmony with regulations.
Note: Use this promocode(117660) for 10% discount.