This Risk Management webinar/training will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections.
Many FDA regulated companies utilize numerically based risk management techniques such as FMEA and RPN to determine where to focus their risk mitigation activities. This presentation will describe enhancements to these techniques that can improve your relationships with customers and regulatory agencies, resulting in a reduced number of surprises during inspections. The bottom line is a protection or enhancement of your bottom line and a (correct) perception that you are responsive to the right issues.
Areas Covered in the seminar:
- What are the FDA and ISO requirements for risk analysis and control?
- What is a typical pre-release risk management system?
- What is a typical post-release risk management system?
- Why are the typical approaches insufficient?
- How to develop additional criteria for a more comprehensive risk management system
- Why should you listen to your gut?
- Real world examples of the preceding principles
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that have risk management systems. The employees who will benefit include:
- Quality management and personnel
- QA managers and personnel
- Engineering and Manufacturing managers
- Consultants
Instructor Profile:
Roger Greenwald, is a principal of NJK & Associates, Inc., a consulting firm that specializes in Quality and Regulatory Affairs for medical device and IVD manufacturers.He has more than 30 years experience in manufacturing industries, with more than 20 related to medical devices. He has held line and management positions in R&D, manufacturing, and quality, and currently holds 38 US patents for medical, surgical, and consumer devices. His front-line industry experience dealing with customers, complaints, failure investigations, risk analyses, and inspectors bring a real-world perspective to his presentations. He is known for challenging the status quo and helping students toward tangible improvement in their systems.
