San Francisco, California
London, United Kingdom
Pharmaceutical gases such as Compressed, Nitrogen Argon gas systems used for the production of finished pharmaceutical or other types of products may either have direct or indirect impact to the finished products. These gases are also used for other medical and non-routine processes hence understanding the design, validation, routine monitoring, data management, failure investigations, regulations and applicability of each type of gas system ensures compliance to the required regulations. A detailed technical understanding of how to perform these critical steps during the initial evaluation or re-evaluation of a new, modified or existing gas system will eliminate expensive failure or remediation issues, inability to perform validation as well as routine testing and maintenance issues which ultimately impact or delay the release of the affected product.
This 2 days seminar will provide the attendee an extensive technical and practical knowledge that includes 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 investigation, excursion or out of specification results and trending so as to avoid the high cost associated with a poorly designed system. This seminar contains a lot of technical content, case studies, practical discussions and an exciting learning environment.
Why you should attend:
This seminar will provide an enormous amount of technical information and will be beneficial to those involved in the establishment, design, installation, validating, testing, review and approval of a new and modified or existing pharmaceutical gas programs so as to meet the requirements of ISO 8573, USP or FDA requirements. It will also benefit the vendors and suppliers of pharmaceutical gases to ensure compliance to the different regulatory bodies’ requirements.
Upon completion of this seminar, the attendees will be able to:
- List the applicable regulations and how it applies to the different types of gases.
- Plan, define, design, re-design, appropriately install, validate, routinely test and remediate a gas system to avoid future failure and to achieve compliance to regulations.
- Define and design a robust Analytical and Microbiological testing program for pharmaceutical gases with each defined specific assay required for each type of gas system.
- Design a robust pharmaceutical gas testing trending program and defining the alert and action levels for each test methodology to ensure a state of control for the gas systems.
- Perform analytical and microbiological gas testing data review and management and utilizing the data for gas testing trend reports.
- Perform Out-of-specification, Alert and Action Levels Excursion, Contamination or Failure Result investigation and Remediation of routine gas testing program.
Who will Benefit:
This seminar 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, especially:
- Quality Assurance Personnel and Management
- Quality Control Personnel and Management
- Laboratory Managers
- Testing Analysts and Technicians
- Manufacturing Personnel and Management
- Suppliers and Vendors of Pharmaceutical Gas Systems
- Validation Personnel and Management
- Supplier Quality Assurance Personnel and Management
- Regulatory Affairs Personnel and Management
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.