Expert Profile
Ronald Schoengold
Principal, eGold Solutions Consulting
Ronald Schoengold, has been an active contributor to the medical device, pharmaceutical and biomedical environment for over 45 years. As a consultant to both large and small companies, he offers expert advice on quality systems, regulatory submissions and resolution of regulatory and quality problems. He is also an experienced auditor in clinical research, supply chain and manufacturing (GMPs). Ron is certified in regulatory affairs and has a proven record of accomplishment for integrating quality and regulatory requirements with technical, organizational and business development needs. He offers critical advice on the effective commercialization, support and maintenance of medical products and services and is an advisor to the National Institutes of Health, Commercialization Assistance Program, assisting companies awarded SBIR grants. Ron has published, presented or contributed to more than 16 scientific publications including a book chapter on point-of-care testing. He holds 8 patents related to point-of-care diagnostics.
Trainings by Expert
Risk Management for Medical Devices: ISO 14971:2007
Category:
Medical Devices
,
Risk Management
,
Risk Management & Controls
,
All FDA Regulated Functions
,
Life Sciences
Root Cause Analysis for Corrective and Preventive Action (CAPA)
Category:
Medical Devices
,
All FDA Regulated Industry
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life Sciences
Developing a Robust CAPA System
Category:
All FDA Regulated Industry
,
Quality Management
,
Quality and Safety
,
Life Sciences
Internal Quality Audit: Identifying Corrective and Preventive Actions
Category:
All FDA Regulated Industry
,
Quality Management
,
Audits, CAPA
,
Audit & Inspection-Role
,
Quality Audit
Quality Planning Process and Procedure
Category:
Medical Devices
,
General Manufacturing
,
Quality Management
,
Best practices
Quality System Training Requirements
Category:
Medical Devices
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Life sciences QA/QC
,
Life Sciences
,
QA/QC
Clinical Research Organization Audit for Good Clinical Practice
Category:
Drugs and Chemicals (Pharma)
,
Clinical Research
,
GCP & Other Best Practices
,
Life Sciences
