ComplianceOnline

Expert Profile


David L Chesney
Principal and General Manager, DL Chesney Consulting LLC

David L. Chesney, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. He has 47 years experience, evenly divided between the FDA and the private sector, including over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.

Mr. Chesney has an MS degree in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of the Parenteral Drug Association, where he serves on the faculty of the PDA Training and Research Institute. He is also active in the Food and Drug Law Institute and RAPS.

Trainings by Expert

The FDA Compliance Enforcement Process
Category: Drugs and Chemicals (Pharma) , Medical Devices , Risk Management , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , Audits & Inspections , Crisis Management , Supply Chain and Manufacturing , Drugs Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Drugs Inspections , Life sciences QA/QC , Compliance & Ethics , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Performing Effective Management Review of the Quality System
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Food & Dietary Supplements , Manufacturing & Contamination control , Drugs Regulations , Biotech Regulations , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations , QA/QC

Executive Exposure under Strict Liability Doctrine in FDA Enforcement
Category: All FDA Regulated Industry , Corporate Governance , Compliance & Ethics , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Common FDA Regulations

Integrating Pharmacovigilance and Technical Complaint Systems
Category: Drugs and Chemicals (Pharma) , Risk Management , All FDA Regulated Industry , GXP Pharmaceutical , Quality and Safety , Drugs Regulations , Risk Management & Controls , All FDA Regulated Functions , Audit & Inspection-Role , Drugs Inspections , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

Effective Deviation Investigators Under GMP
Category: Drugs and Chemicals (Pharma) , Laboratory Compliance , All FDA Regulated Industry , Testing and Validation , Documentation and IT , Quality and Safety , Audits & Inspections , Laboratory , GLP & Other Best practices , Analytical Laboratory , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Effective Systems for Change Control in the Pharmaceutical Industry
Category: Drugs and Chemicals (Pharma) , Quality and Safety , Audits & Inspections , Supply Chain and Manufacturing , Drugs Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

How to Prevent cGMP Violations & Warning letters - Training for Pharma Manufacturing
Category: Drugs and Chemicals (Pharma)

GMP Compliance for Quality Control and Contract Laboratories
Category: Laboratory Compliance

Conducting Effective Mock FDA Inspections
Category: FDA Audit and Inspection