ComplianceOnline

Expert Profile


Carolyn Troiano
ERP Project Manager, City of Richmond

MBA, is an independent consultant with more than two decades of experience working in pharmaceutical and biotechnology companies in roles related to CSV policy and program development, implementation, assessment, management and budgetary oversight. Carolyn has worked for more than three dozen companies, either directly or as a consultant specializing in FDA CSV, including 21 CFR Part 11. In addition, she has provided guidance, training and mentoring to client staff, building capability within these organizations. Carolyn was involved in CSV when the original "FDA Blue Book" was issued in 1983, and played a role as an industry representative in reviewing and contributing to Part 11 requirements.

Trainings by Expert

Validation for FDA and ISO 13485 Compliance: Pack of Two Courses
Category: Medical Devices , All FDA Regulated Industry

Integration of ERP and Legacy FDA-Regulated Systems
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , Testing and Validation , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Laboratory , Quality & Safety , IT Regulations , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Risk Management & Controls , All FDA Regulated Functions , 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

FDA Compliance and Laboratory Computer System Validation
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , Laboratory Compliance , 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 , Supply Chain and Manufacturing , Laboratory , Clinical Laboratory , Analytical Laboratory , Quality & Safety , Technologies and Processes , IT Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

Data Governance for Computer Systems Regulated by FDA
Category: Drugs and Chemicals (Pharma) , Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , 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 , Laboratory , Technologies and Processes , IT Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products
Category: Drugs and Chemicals (Pharma) , Packaging and Labeling , All FDA Regulated Industry , Food Safety Compliance , Food & Dietary Supplements , Manufacturing & Contamination control , Drugs Regulations , Regulations & Guidances , Life Sciences , Regulatory Affairs

FDA Compliance and Clinical Trial Computer System Validation
Category: Clinical Research , All FDA Regulated Industry , Audits & Inspections , Clinical Trial Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

Trial Master File and Clinical Data Management Regulated by FDA
Category: Clinical Research , Risk Management , Audits & Inspections , GCP & Other Best Practices , Trial Design and Management , Clinical Trial Regulations , Audit & Inspection-Role , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

In-Depth Testing of Computer Systems Regulated by FDA
Category: All FDA Regulated Industry

Developing a Strategic Approach to FDA Compliance for Computer Systems
Category: All FDA Regulated Industry

C-TPAT Compliance for FDA-Regulated Industries
Category: All FDA Regulated Industry