ComplianceOnline

Expert Profile


David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton, is an industry leader, author, and instructor on topics pertaining to 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 250 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Trainings by Expert

GAMP® Validation Protocols for Efficient Documentation
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

Using Excel Spreadsheets in FDA Regulated Environment
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Documentation and IT , Risk Management & Controls , All FDA Regulated Functions , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Documentation and IT , Quality and Safety , Risk Management & Controls , All FDA Regulated Functions

Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Risk Management & Controls , All FDA Regulated Functions , Life Sciences , Documentation and Data Management

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Category: All FDA Regulated Industry , FDA Audit and Inspection , FDA 21 CFR Part 11 , Documentation and IT , Audit & Inspection-Role , All FDA Reg. based Audit , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

How to Buy COTS Software, and Audit and Validate Vendors
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Laboratory , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

HIPAA Compliance for Electronic Records
Category: HIPAA Compliance , Healthcare Compliance (Hospitals) , HEALTHCARE , Hospital Management , Audit & Data Security , HIPAA , IT Regulations , Healthcare Regulations , Audit & Inspection-Role , Healthcare Audit , Regulatory Affairs

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , FDA 21 CFR Part 11 , Testing and Validation , Documentation and IT , Quality and Safety , Quality & Safety , Technologies and Processes , IT Regulations , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Technologies and Processes , Drugs Regulations , Biotech Regulations , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC