Pharmaceutical Gas Systems

Who Should Attend
The course will benefit those involved in manufacturing, using, testing and Validating pharmaceutical gas systems in various industries such as the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device and In-vitro Diagnostics Product Manufacturing Industries. It will be especially valuable to: 

  • Laboratory Managers
  • Testing Analysts and Technicians
  • Suppliers and Vendors of Pharmaceutical Gas Systems
  • Personnel and Management in: 
    Q/A, QC; Manufacturing; Validation; Supplier QA; 
    Regulatory Affairs; Shipping and Receiving; Facility and 
    Maintenance; Engineering; Materials Management

Description
Pharmaceutical gases such as Argon, Compressed and Nitrogen systems are critical and have a direct or indirect product impact to finished products that are manufactured within the cleanrooms. This course will allow the attendee to understand the regulations, applicability, design, validation, routine monitoring, data management and failure investigations in order to enhance the user’s compliance to the required regulations. Understanding the critical steps during the initial evaluation or re-evaluation of a new, modified or existing gas system will eliminate loss of a batch of product, production delays, compliance issues, expensive failure remediation issues, inability to perform validation as well as routine testing and maintenance issues. Gas failure investigation arising from a poor design and lack of knowledge of the regulations has a high impact to the production of finished products hence this seminar will prepare the attendee to have an understanding of the step by step process of evaluating a new gas system through the design, installation, validation, routine monitoring/testing, data management, performing a gas failure, excursion or out of specification results and trending. This seminar will be packed with a lot of technical information, case studies, practical discussions and an exciting learning environment.