This FDA compliance training will review the FDA Software Standard "General Principles of Software Validation". The process that FDA investigators use relative to software failure investigations will also be discussed.
Many companies are confidant that their software system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 software related cites are written and warning Letters, seizures or worse ensue. This presentation will review the FDA Software Standard "General Principles of Software Validation". Understanding this guidance is vital for compliance and for regulatory submission success I will address auditing techniques relative to this standard. The process that FDA investigators use relative to software failure investigations will also be discussed.
Areas Covered in the seminar:
- "Using the FDA guidance "General Principles of Software Validation" to strengthen your firm’s software FDA compliance"
- QSIT software audit process
- How do I counteract a possible FDA 483 cite
- Where does risk management fit in
- How do I correct the FDA compliance gaps in my software compliance processes
- Should I automate my quality management system
- How do I better audit my software systems
- How do I train my staff in regards to maintaining software systems compliance
What will students Learn:
- How do I answer an FDA 483 software cite
- How do I improve my software auditing
- What type of resource commitment is there achieve compliance
- what are the key elements of the standard
Who will benefit:
This webinar will provide your firm with key insights on how to better understand the FDA guidance "General Principles of Software Validation" . 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
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.
