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
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
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
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
Acceptance Activities in FDA QSR
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Life sciences QA/QC
,
Life Sciences
,
Regulatory Affairs
,
QA/QC
Post Market Surveillance for Medical Devices
Category:
Medical Devices
,
Marketing and Promotion
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
Sampling Plan for Quality Audits
Category:
Medical Devices
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Audit & Inspection-Role
,
Quality Audit
,
Lab Audit
,
Life Sciences
,
Documentation and Data Management
Preparing for FDA's Unique Device Identification Rule
Category:
Medical Devices
,
Marketing and Promotion
,
Audits & Inspections
,
Supply Chain and Manufacturing
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
Common FDA Regulations
,
QA/QC







