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Expert Profile
Daniel O Leary
President, Ombu Enterprises, LLC
Is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Trainings by Expert
Medical Device Risk Management Using ISO 14971
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
Excel Spreadsheets and FDA Device Regulations
Category:
Medical Devices
,
FDA 21 CFR Part 11
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
,
Documentation and Data Management
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
Category:
Medical Devices
,
Process Manufacturing
,
General Manufacturing
,
R & D
,
Life Sciences
A Unified Approach to Complaints, Servicing, and FDA Reporting
Category:
All FDA Regulated Industry
,
FDA Audit and Inspection
,
Marketing and Promotion
,
Documentation and IT
,
Life Sciences
Fundamentals of Process Validation
Category:
Medical Devices
,
FDA Validation
,
Supply Chain and Manufacturing
,
Life Sciences
Statistical Concepts of Process Validation
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Life Sciences
Full Day Virtual Seminar: Medical Device Process Validation - FDA Inspectors are Checking - Are You Prepared?
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Life Sciences
Integrating Clinical Evaluation and Risk Management
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
DMR & DHR - What Is Really Required
Category:
Medical Devices
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
,
Regulatory Affairs
From Premarket Notification to Recalls - Comprehensive Medical Device Regulations Training Package
Category:
Medical Devices