This Risk Management webinar/training will explain how to integrate risk management in to the quality management system.
Why Should You Attend :
Many companies are confident that their risk management process is compliant “enough” to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 cites are written and Warning Letters, seizures or worse ensue. Internal audits show the firm meets FDA risk analysis requirements, yet FDA writes the firm up.
This presentation will review processes for integrating a reasonable level of risk management into the quality management system. Much emphasis will be placed during the talk on the risk management elements of the design control regulation, along with CAPA risk management concepts.Actual FDA investigator training methods related to specification holder inspections will be discussed Real life examples of FDA compliance issues will be examined.
Areas Covered in the Seminar:
- How do I create an adequate Risk Management File?
- How do I answer an FDA 483 cite?
- Key mistakes in auditing practices.
- Just what level of control does FDA have over this area.
- How do I beat back a FDA 483 point.
- How I do gain ISO 14971 compliance.
Who will benefit:
This webinar will provide your firm with key insights on how to identify compliance gaps in your risk management processes. The webinar will help you avoid FDA 483's and warning letters the employees who will benefit include:
- Regulatory Managers
- QA managers and personnel
- RA managers
- Quality Engineers
- Internal auditors
- Consultants
Instructor Profile:
Dennis M. Moore, is the President CEO and Founder of AUK Technical Services LTD (ATS). a worldwide consulting firm which specializes in Quality Systems and submissions for medical device and pharmaceutical companies. Mr. Moore is a former 22 year FDA credentialed Government investigator, Retired Peace Officer and author of many articles on quality system concepts. Mr. Moore has performed hundreds of FDA device and drug inspections, and written many FDA 483 and warning letter citations. He also has industry experience on the manufacturer side of the auditing desk.
