What are best practices for creating a Risk Management File?

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.

Areas Covered in the seminar:

• What are best practices for creating a Risk Management File?
• QSIT audit processes regarding risk management.
• How do I counteract a possible FDA 483 cite?
• What should be in my Risk Management File?
• How do I correct the FDA compliance gaps in my risk management process?
• How do I better audit my design control processes ?

Who will Students Learn:

• How do I answer an FDA 483 cite?
• Key mistakes in auditing practices.
• What type of resource commitment is there to achieve risk management 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 employees
• Government Auditors
• Quality System Auditors
• Industry Consultants
• ISO 13485:2003 auditors

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.

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