Excipients: Compliance with Compendial and GMP Requirements

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"

Excipients must be evaluated with each drug they are included with to ensure that they can be used safely

Description

Excipients are the substances that are in any pharmaceutical preparation besides the drug.  From ingredients that improve drug delivery, to ingredients that improve stability of the drug to ingredients which improve the color and taste of the drug, each component has a key role in pharmaceutical delivery and must be evaluated as such

Why Should You Attend

Excipients must be evaluated with each drug they are included with to ensure that they can be used safely while ensuring the drug can be used as intended.  However, there are a number of challenges with excipient testing.  Balancing the needs of the various compendials, such as USP, EP and JP, with cGMP can be a challenge.  The goal of this webinar is to ensure that you know what needs to be done for each type of testing, the goals of each, and how you can use the various components of testing to reinforce each other to ensure the proper usage of excipients.

Areas Covered

  • Types of excipients
  • Compendial excipient testing
  • cGMP excipient testing
  • Balancing the use of the various standards
  • Challenges with excipient testing
  • Cooperation with stakeholders in excipients

Who will Benefit

  • Quality Control/Quality Assurance
  • Regulatory Affairs
  • Laboratory staff
  • Manufacturing staff

Industries who can attend

This 60 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. 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.

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