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

Description

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.

Areas Covered

•     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.


Speaker Profile

Todd Graham

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. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

Back to Top