Expert Profile
Jonathan M Lewis
Principal, Advanced Biomedical Consulting LLC
Jonathan M. Lewis, has over 22 years’ experience in the areas of quality control/quality assurance (QA/QC), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal feed industries.
Prior to founding Reliant FDA Experts (Reliant) (ABC), LLC, Jonathan worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in the Sterility Assurance Laboratory.
Trainings by Expert
Building a Vendor Qualification Program for FDA Regulated Industries
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Clinical Research
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
Documentation and IT
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Supply Chain and Manufacturing
,
Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Biotech Regulations
,
Audit & Inspection-Role
,
Medical Device Inspection
,
Lab Audit
,
Drugs Inspections
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
QA/QC
Preparing for and Managing FDA Inspections
Category:
Drugs and Chemicals (Pharma)
,
Medical Devices
,
Clinical Research
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
FDA Audit and Inspection
,
FDA Validation
,
Testing and Validation
,
Documentation and IT
,
Quality and Safety
,
Audits & Inspections
,
QMS, ISO 13485, CAPA
,
Laboratory
,
Quality & Safety
,
Food & Dietary Supplements
,
Drugs Regulations
,
Clinical Trial Regulations
,
Biotech Regulations
,
Audit & Inspection-Role
,
Quality Audit
,
Food Safety Audit
,
All FDA Reg. based Audit
,
Medical Device Inspection
,
Lab Audit
,
Drugs Inspections
,
Clinical Research Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
Common FDA Regulations
,
QA/QC
