A Comparison in Terms and Application for Drugs and Biologics
A Comparison in Terms and Application for Drugs and Biologics
Why Should You Attend:
In this seminar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This seminar will define the terms and their application in the development environment.
During product development within an organization that has yet to commercialize a product, the use of the terms GLP and GMP are often confused and may be used incorrectly. Doing so can result in reducing credibility by regulatory health authorities. The objective of this seminar is to define the terms, how they are.
Areas Covered in the Seminar:
Nomenclature.
How the GLPs and GMPs came to be an their evolution.
The major sections of GMPs.
When to apply GMPs.
The major sections of GLPs.
When to apply the GLPs.
A comparison of the two.
Avoiding confusion.
Who Will Benefit:
This seminar would be beneficial to anyone that plays any leadership role in an FDA manufacturing environment to produce, test, warehouse and/or ship biologics or pharmaceuticals, including:
Leaders in manufacturing
Quality control
Quality assurance
Warehouse functions
Directors/Managers in regulatory affairs
Document control
Development and nonclinical functions
Instructor Profile:
Janet Rose Rea, Ms. Rea recently joined the faculty at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She also has two consulting firms. Most recently, she held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 2010 and AVI BioPharma from 2003 2008. She was also a corporate officer for both organizations.
Trained as a public health microbiologist at the University of Washington, Ms. Rea started her career with American Dade Division, American Hospital Supply Corporation in Miami Florida in the microbiology quality assurance group, applying microbiological techniques to improve aseptic processing and reducing product failure. Thereafter, she returned to Seattle, working for Genetic Systems, Immunex where she played a key role in the approval of the company's first product, LEUKINE, MDS Panlabs, and Targeted Genetics. Her diverse experience transcends the product development continuum in a variety of therapeutic areas, especially oncology and rare genetic diseases.
For More Details:
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