ComplianceOnline

Expert Profile


Andrew Campbell
Pharmaceutical Consultant, Quality & Compliance

Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of Deviation-CAPA, Change Control, GMP Auditing, GMP Training, and Regulatory Inspection Preparation & Management.

Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key Quality Systems. He is a skilled GMP Auditor, and has audited multiple API, Drug Product, Packaging, Testing and Distribution facilities. Mr. Campbell is an experienced GMP Trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring of written responses to inspectional observations.

Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as Director of Quality Systems.

Trainings by Expert

Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Category: Drugs and Chemicals (Pharma) , Laboratory Compliance , All FDA Regulated Industry , Testing and Validation , Quality and Safety , Audits & Inspections , Laboratory , Drugs Regulations , Audit & Inspection-Role , Lab Audit , Drugs Inspections , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Conducting Effective Quality Audits: Beyond Audit Checklists
Category: Drugs and Chemicals (Pharma) , Medical Devices , All FDA Regulated Industry , Quality and Safety , Audits & Inspections , QMS, ISO 13485, CAPA , Drugs Regulations , Audit & Inspection-Role , Quality Audit , Medical Device Inspection , Drugs Inspections , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

Change Control Best Practices: Avoiding Unintended Consequences of Changes
Category: All FDA Regulated Industry , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC