Transitioning Assays From Different Technologies: Validation and Qualification

Description:

Laboratories need to transition technologies all of the time. From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another. With this seminar, you will be able to fully understand how your assay is currently running and make note of what the new technology should be able to do. Then you will learn how to slowly get the new technology up and running, validating the quality system, equipment and the assay itself. You will learn what you need to understand in the process of transitioning old samples onto the new system and deal with any potential issues. Finally, you will develop a final validation plan that will allow you to embrace the new technology fearlessly.

Course Objective

• Validating your new assay technology
• Creating an assay transfer plan
• Implementing and performing an assay transfer plan
• Monitoring the results of assay transfer validation
• Green-lighting the new technology

(View More)

Course Outline

• Defining assays
• Understanding current assay processes
• Identifying stakeholders for the assay
• Developing a plan for transitioning the assay
• Understanding what samples to use
• Monitoring the results of assay validation to identify challenges
• Adapting the workspace to new assay requirements
• Training the stakeholders for work changes due to new assay

Target Audience

• Biotechnology firms
• Pharmaceutical companies
• Clinical laboratories
• Chemical laboratories
• Quality Assurance Professionals
• Research & Development Professionals
• Quality Control Managers
• Manufacturing Managers
• Supervisors and Technicians

   

  Speaker: Todd Graham,

  Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a broad level of expertise in assay development for quality control, pharmaceutical development and clinical diagnostics. His particular levels of expertise are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.

   

  (View in Website)

  To register/enquire, please contact:

  www.compliance.world

  Call us at this Toll Free number: +1-866-978-0800