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.
U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820). They are then required to translate those regulations into procedures and work instructions. Many companies who have successfully done that in the past are now failing audits, facing major recall, and multi-million dollar fines. What failures in the GMPs have led to this? What assumptions have proven to be invalid? What are the key areas of non-compliance? What can be done in a company to look for, validate or correct to prevent it from being the next news headline or "60 Minutes" feature? What new concerns need to be addressed now? How can companies make such determinations? What approaches are now mandated? How does ICH Q9 or ISO 14971 Risk Management fit into the process? How to maximize any remedial action process against scarce resources? .
This 90-minute webinar will answer all the above.
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
- Production
- 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.
