Mr.Roger Cowan

Area Of Expertise : Sterilization
35 Years Of Experience
Training Industry : Life Sciences

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, Roger has held various manager  director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution.  Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.    
Roger's areas of expertise include  aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoringcontamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US  International regulatory requirements, regulatory submissions, and quality assurance control. 
 

6 results Found
Recorded Webinar

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Environmental Monitoring looks at the end results of the Environmental Control Program – the microbiological and particulate quality of the cleanroom. As the FDA Guideline on Aseptic Processing GMP (2004) states:    “In aseptic processing, one of the most im ...

  • Intermediate
  • 60 Mins
On-Demand Webinar

HVAC and GMP Environmental Control for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, tem ...

  • Basic & Intermediate
  • 60 Mins
On-Demand Webinar

Pharmaceutical Compressed Air: Quality GMP Standards and Requirements

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction, and monitoring of a compressed air system are essential for maintaining a quali ...

  • Intermediate
  • 60 Mins
On-Demand Webinar

HVAC and GMP Environmental Control - for Pharmaceutical Clean Rooms

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperatur ...

  • Intermediate
  • 60 Mins
Recorded Webinar

Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides the assurance of sterility in the finished drug product. Therefore, the design, validation and ongoing monitoring of a ster ...

  • Intermediate
  • 60 Mins
On-Demand Webinar

CMO Supplier Quality Agreements: How to Comply with new FDA and EU Guidelines for Contract Drug Manufacturers

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well-publicized quality issues with CMOs, make it a necessity to hav ...

  • Intermediate
  • 60 Mins