E-
Learning
Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
États-Unis, Palo Alto
Entrée : 199,00 $ (HTVA)
Price is for One Dial-in One Attendee
Public ciblé:
Quality assurance
Environmental monitoring
Microbiology
Manufacturing
Validation
Engineering
Maintenance
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
Objectives :
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.
A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal.
The four contamination sources in compressed air will be discussed. They are:
- Solid particulate
- Water content
- Total oil content
- Microbial bioburden
For each of these, the presentation will discuss cause and effect. Suggestions will also be provided for preventing contamination. Finally, a compilation of all FDA/EU GMP guidelines, USP/EP and ISO air standards will be presented. Sampling and testing methodology for each of these specifications will be discussed as well.
Compliance online location :
- ComplianceOnline.com, MetricStream Inc.
- 2479 East Bayshore Road
- Suite 200
- Palo Alto, CA 94303
Registration contact :
- Name : Mohammad Irshad
- Email: Mohammad.Irshad@ComplianceOnline.Com
- Phone: +1 650-332-0381
- Fax: +1 650-565-8542
Areas covered in the Webinar :
- Compressed Air - Importance of Quality
- Pharmaceutical Compressed Air System Design
- Contamination Types and Sources
- Contamination Prevention
- International GMP Testing Standards
- Testing Methods and Specifications
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Roger Cowan
Pharmaceutical Consultant
R Cowan Consulting Services LLC
Résumé
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.