Validating Radiation Sterilization for Medical Device Industries
Validation is based on the international standard ISO 11137-1:2006 and ISO 11137-2:2006. In this one hour seminar you will obtain a basic understanding of the principles, core requirements of the ISO standard as well as related standards and guidance. We will define how radiation sterilization works, the equipment involved, major issues with product sterilization via radiation, and the validation requirements. Routine process control and monitoring will be reviewed along with requirements to maintain the process effectiveness.
Why should you attend:
Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.
Areas Covered in the Session:
Who Will Benefit:
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:
Why should you attend:
Radiation sterilization validation is a topic that results in many audit observations from the FDA and international regulatory bodies. Proper understanding of the principles and requirements of the related standards is crucial to proper compliance. In addition, understanding the requirements and integrating them early in the product design can lead to quicker time to market. This seminar will help RA/QA staff understand the basic principles as well as the standards and regulations. This will be useful when reviewing validation plans, performing internal audits and dealing with regulators. It is also beneficial to R&D staff to understand the requirements so they may be incorporated into the design inputs correctly.
Areas Covered in the Session:
- Introduction
- Terminology / Definitions
- Radiation characterization / effectiveness
- Process Equipment
- Product and Material Issues
- Process Definition
- Validation IQ/OQ/PQ
- Documentation, review and approval of validation
- Routine Monitoring
- Product Release
- Maintenance of process effectiveness
Who Will Benefit:
- RA Directors, Managers and Staff
- QA Directors, Managers and Staff
- Internal Audit Staff
- R&D Directors, Managers and Staff
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884
GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.
GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:
- Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations
- Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs
- One stop destination for all your queries and to share and discuss issues, ideas and best practices and
- A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.
