Pharmaceutical Compressed Air - Quality GMP Standards And Requirements

PHARMACEUTICAL Apr 20, 2017 60 minutes
01:00 PM EST 12:00 PM CST 11:00 AM MST 10:00 AM PST

Description:

Clean rooms need to be absolutely free from contamination, it so happens that many institutions neglect compressed air as a probable cause of clean room and product contamination. This conference aims to give an insight on the different types of contamination sources particularly compressed. We will also focus on the the different ways to prevent your system from being affected.

Why should you attend?

Participants of this webinar will gain working knowledge on contamination prevention, in particular that related to compressed air. The conference will cover the following:

  • Descriptive study of pharmaceutical compressed air systems including the individual components. The study includes detailed engineering diagrams. Component functions are also explored and recommendations given on the optimal component types.
  • An insight on the four sources of contamination in compressed air, these are:
  1. Solid particulate
  2. Water content
  3. Total oil content
  4. Microbial bioburden
  • Prevention of contamination by the above mention sources is discussed
  • Presentation of all FDA/EU GMP Guidance, USP/EP and ISO air standards.

Areas Covered in the Session:

  • The importance of quality Compressed Air
  • Pharmaceutical Compressed Air System Design
  • Sources of Contamination
  • Prevention of Contamination
  • International GMP Testing Standards

Who will benefit:

The following departments, personnel and professionals will benefit from participating in this webinar:

  • Quality assurance departments
  • Environmental monitors
  • Microbiology institutions
  • Manufacturing
  • Validation
  • Engineering
  • maintenance
Presenter BIO

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 of 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 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.

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