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COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
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COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
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COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
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Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
Boston Professional Events List
Live Webinar 60 minutes SOP's for Bioanalytical Methods Validation
Link to Website
Bioanalytical assays are used in a variety of laboratory contexts, from clinical laboratories, to research and development, to quality control and manufacturing. These laboratory assays have become crucial to the regular operations of all sorts of laboratories. However, each assay has particular pitfalls that makes transitioning from one assay to another difficult. Each type of bioanalytical assay has its own particular challenges and opportunities, and understanding where the opportunities are is key to making sure validations are successfully completed.
This assay will cover the three broad classes of bioanalytical assays: immunoassays, molecular assays and mass spectrophotometry based assays. We will look at the particular advantages and challenges in each class, how to operate within ease class and the key challenges in moving between classes. This will ensure that assay validation goes off without a hitch, and new assays can be deployed in a timely manner.
Objectives Of the Session
1. Defining what a bioanalytical method is
2. Necessary steps to validate an immunoassay
3. The challenges and opportunities of validating a molecular assay
4. Needs for mass spectrophotometry assays
5. Issues in transitioning between assay classes
6. Best practices for all bioanalytical methods
Who will Benefit
• Quality control
• Assay Development
• Assay validation
• Research and Development
• Clinical Diagnostics
Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities.
(Contact us : 844-267-7299 | 954-947-5671
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