Validation of Pharmaceutical Compressed Gasses

Duration: 75 Minutes
Compressed gasses are vital excipient and utility in pharmaceutical and bio-pharmaceutical industry. Their criticality to pharmaceutical and bio-pharmaceutical production sometimes overlooked. Their potential to be a source of clean room and product contamination seldom considered.
Validation of Pharmaceutical Compressed Gasses
Instructor: Igor Gorsky
Product ID: 504645
This webinar will give you an understanding of different types of compressed gasses used in pharmaceutical and bio-pharmaceutical industry and their purpose, designs of these utility systems and their qualification and validation considerations as well as continued monitoring throughout life-cycles of these systems.

Objectives of the Presentation
  • Compressed Air Systems coverage
  • Selection of the compressed air systems
  • Major components of systems (schematics)
  • Criticality of major components
  • Qualification of compressed air systems
  • International standards and pharmacopeia testing specifications
  • International guidance
  • Validation of compressed air systems
  • Contamination potential examples (case studies) and prevention
  • Optimization, qualification and validation planning and implementation for post-expansion and/or post-changes
  • Nitrogen Systems coverage
  • Special considerations for design
  • Qualification of nitrogen systems
Other Gasses:
  • Argon
  • Liquid Nitrogen
  • Carbon Dioxide
  • Cryogenic Storage Solutions
  • Oxygen
  • Special considerations for design
  • Qualification of special gas systems
Why Should you Attend
We will also discuss possibilities of contamination types inherent in compressed air and other gasses systems and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed gasses system with their individual components will be provided.

Who will Benefit
  • Quality Control
  • Quality Assurance
  • Production/Operations
  • Microbiologist
  • Chemist
  • Analysts
  • Manufacturing
  • Validation
  • Facilities
  • Materials Management
  • Engineering
  • Vendors/Suppliers
  • Regulatory Affairs
  • All levels of management
$299
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex. He is also very active with PDA participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.
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