Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

Product Id : FDA07
Instructor : Roger Cowan
Mar 06, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

Description

Overview

Compressed air is considered a crucial service in pharmaceutical use, as most of its applications involve direct contact with the product. As such, it is important that the compressed air system used is designed, constructed and monitored well. This ensures a strong quality system that keeps contamination at bay.

Compressed air can cause clean room and product contamination, but people often overlook this possibility. It is very important to have a good compressed air system in place, to ensure a contamination-free product. However, to prevent contamination from occurring, you need to first understand the different types of contamination commonly found in compressed air, and how you can prevent your system from getting affected by them.

During this webinar, our expert speaker will walk you through the subject, furnishing information which will help you perform your duties better. You will obtain a detailed description of a typical pharmaceutical compressed air system, which points out its individual components and includes engineering schematics. It will also include component functions, and recommendations for optimal component types.

There are four main sources of contamination, which will be discussed during the webinar. These are: solid particulate, water content, total oil content, and microbial bioburden. For each, our speaker will discuss its cause and effect, and prevention strategies.

For validation and system monitoring purposes, you need to regularly test compressed air quality according to international standards. This subject will also be under discussion, and attendees will be presented with a compilation of FDA/GMP Guides, USP/EP as well as ISO air standards. Our speaker will discuss sampling and testing methods for each of these specifications

Sign up for this webinar to understand contamination, to prevent the problem from arising. Knowing proper testing methodology according to international standard will help you stay in compliance.

Training Highlights:

  • Learn the importance of compressed air quality
  • Learn about the pharmaceutical compressed air system design
  • Learn the various types of contamination, and its sources
  • Learn how to prevent contamination
  • Learn about the international GMP testing standards
  • Learn sampling and testing methods for various specifications

Who will benefit?

The following people will benefit from, and should therefore attend this webinar:

  • Environmental Monitoring Personnel
  • Persons working in Pharmaceutical Manufacturing
  • Quality Assurance Professionals
  • Personnel responsible for maintenance
  • Professionals in the field of Microbiology
  • Manufacturing Personnel
  • Validation Personnel
  • Engineers
Speaker Profile:

Roger Cowan is the owner of R Cowan Consulting Services LLC, which is a consulting firm which specializes chiefly in pharmaceutical contract manufacturing. He has been working in the field of pharmaceutical quality assurance and manufacturing for over 37 years, and in this time, he has held important positions in QC Laboratory, Quality Assurance, Manufacturing, Technical Services Validation, and Clinical Supply Manufacturing and Distribution.

He has taught microbiology courses at the Seneca College in Toronto, Canada, as part of the Pharmaceutical Technology Program. In addition, he has conducted webinars on various subjects, providing invaluable training to thousands of people across the nation.

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


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