DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "4 Training Courses on How to Manage FDA 483s and Warning Letters" webinar to their offering.
When the FDA documents that a firm has significant deviations from applicable legal requirements, it will issue that firm a Warning Letter. As an enforcement tool, the FDA Warning Letter tells you that your firm is facing harsh enforcement action unless you correct the errors of your ways. What you say and, more importantly, what you do can make or break your future with the FDA.
The Warning Letter is a regulatory spring board that leads you into treacherous waters. Currently, the FDA aggressively manages Warning Letters. The threat of further legal action is real. You have little, if any, breathing room for mistakes or oversights in your response. By effectively managing your Warning Letter response, you can avoid being a statistic for other legal actions, like seizure, injunction, prosecutions, fines and product detention.
- The Hitchhiker's Guide to 483s and Warning Letters
- The Infamous Form FDA 483: How you respond can make or break you
- FDA Warning Letter Management
- CAPA Training and Causes of Warning Letters due to Lack of Comprehension
Who will benefit?
- IT VPs
- Regulatory Affairs Professionals
- Quality Assurance Managers
- Small Business Owners
- Senior Operations and Finance Executives
- In-house Legal Counsel
- FDA Consultants
- Public Relations Professionals
- Sales and Marketing Executives
- Manufacturing Executives
- Design Engineers
- Third Party Consultants
For more information visit http://www.researchandmarkets.com/research/zkx474/4_training