Good Manufacturing Practices Training | GMP Course

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"

We will review how all of this work should be documented

Description

Training on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices.  This training is intended to ensure that companies are aware of their obligations working in a field regulated by these guidelinesTraining on current Good Manufacturing practices is necessary to ensure that companies maintain their obligations to producing pure and safe drugs and medical devices.  This training is intended to ensure that companies are aware of their obligations working in a field regulated by these guidelines

Why Should You Attend

Current Good Manufacturing Practices (cGMP) are a series of guidelines that are intended to regulate the production of drugs and medical devices to ensure that they are produced in a safe manner.  During this training, you will get an understanding of why they were developed, and how they shape the everyday procedures that oversee any given company’s work in this field.  The organizational structure necessary for work to be performed under cGMP will be explained.  Facilities and the appropriate requirements needed to operate each will be discussed in a broad view.  Procedures, their requirements and their structure will be reviewed to ensure that the work done at your facility will meet cGMP guidelines.  Knowing what each person’s responsibilities and duties are will ensure that the right work is done by the right person at the right time.  Finally, we will review how all of this work should be documented, so that people know what is going on at a given company.

Areas Covered

  • The history of cGMP
  • The rationale of cGMP
  • cGMP systems
  • cGMP facilities
  • cGMP procedures
  • cGMP personnel
  • cGMP documentation 

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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