ComplianceOnline

Expert Profile


Roger Cowan
Pharmaceutical Consultant, R Cowan Consulting Services LLC

Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 35 years’ experience in pharmaceutical quality assurance and manufacturing. In his career, Mr Cowan has held various manager / director positions in quality assurance, QC laboratory, technical services validation, manufacturing, and clinical supply manufacturing and distribution. He has taught courses in microbiology at Seneca College (pharmaceutical technology program) in Toronto, Canada.

His areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US/international regulatory requirements, regulatory submissions, and quality assurance/control.

Trainings by Expert

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Category: Drugs and Chemicals (Pharma) , Quality and Safety , Audits & Inspections , Supply Chain and Manufacturing , Drug Development , Drugs Regulations , Audit & Inspection-Role , 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

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
Category: Drugs and Chemicals (Pharma)

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Category: Drugs and Chemicals (Pharma) , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Drug Development , Life sciences QA/QC , Research & Development , Drug R & D , Life Sciences , QA/QC

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Category: Drugs and Chemicals (Pharma) , GXP Pharmaceutical , Quality and Safety , Supply Chain and Manufacturing , Drugs Regulations , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , QA/QC

GMP Environmental Monitoring for Pharmaceutical Clean Rooms
Category: Drugs and Chemicals (Pharma)