Roger Cowan
Pharmaceutical Consultant at R Cowan Consulting Services LLC
Roger cowan has 32 years of experience in pharmaceutical R&D, manufacturing and QA management. He has established his own Consulting Services LLC, (http://www.pharmaconsultation.com/), Presently he is a Independent consulting to the pharmaceutical industry primarily in the area of pharmaceutical. His specialties 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.
Upcoming Webinar
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Recorded 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 is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.
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CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturing
This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.
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HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
This webinar details and explains the various US and international regulatory requirements for various cleanroom classifications. Environmental control of pharmaceutical cleanroom is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.
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CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:
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Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs to differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.
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