SOP's for Bioanalytical Methods Validation
01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
"Todd Graham is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields"
Advantages and challenges in each class
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.
• Defining what a bioanalytical method is
• Necessary steps to validate an immunoassay
• The challenges and opportunities of validating a molecular assay
• Needs for mass spectrophotometry assays
• Issues in transitioning between assay classes
• Best practices for all bioanalytical methods
Who will Benefit
• Quality control
• Assay Development
• Assay validation
• Research and Development
• Clinical Diagnostics
Industries who can attend
This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.