- System gap analysis
- Implementation planning and execution
- FDA regulations (QSR, GCP)
- NIST Cybersecurity Framework
- ISO standards
- Baldrige criteria
- Auditing - regulatory and standards compliance
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- Product quality assurance
- Innovation process and tools
- Software development methodologies
- Document Management Systems
| - Quality system, regulatory/medical and technical writing
- Innovation management concepts
- Training materials
- Technical standards and regulations
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