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Pharmaceutical Compressed Air - Quality GMP Requirements - Meet FDA and International Quality Standards

Duration : 60 Minutes

Roger Cowan,

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 36 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Qua Read more

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.

Course Objective:

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 is provided.  Engineering schematics are included. All component functions are detailed with recommendations as to which component type is considered optimal.

The four contamination sources in compressed air are discussed. These are:

Solid particulate
Water content
Total oil content
Microbial bio burden

For each of these, the webinar will discuss cause and effect.   Suggestions are also provided for prevention of the contamination. Finally, a compilation of all FDA-EU GMP training, USP-EP and International Quality Standards are presented. Sampling and testing methodology for each of these specifications is discussed.

Course Outline:

• Compressed Air - Importance of Quality
• Pharmaceutical Compressed Air System Design
• Contamination Types and Sources
• Contamination Prevention
• International GMP Testing Standards
• Testing Methods and Specifications

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
• Live Q&A Session

Who Will Benefit:

• Quality Assurance Personnel
• Environmental Monitoring Agencies
• Microbiology Professionals
• Manufacturing Personnel
• Validation Personnel
• Engineering Professionals
• Maintenance Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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