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Course "GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics" has been pre-approved by RAPS as eligible for up to 1.0 RAC credits towards a participant's RAC recertification upon full completion. |
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Why Should You Attend:
In this Webinar, the application of the terms GLP and GMP will be explored, as there is often confusion in their application during development. This
presentation
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,
as well as cause confusion when working with collaborators. The objective of this seminar is to define the terms, what they mean and how they are applied.
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, is currently the Chief Compliance Officer for Protein Sciences Corporation. She is also in her last quarter as an Assistant Clinical Professor at the University of WA, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. Her consulting firm, QARA Services, LLC, is currently on hiatus. 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. While at Dade she was promoted to the head of Biologicals QA, where she was responsible for several product lines that accounted for over $100M in revenue. 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, infectious and rare genetic diseases, throughout the life cycle.
She has been active in training and lecturing on a variety of compliance topics.
She is a member of two Editorial Advisory Boards, and has lectured extensively as well as published. She received a Bachelor of Science in Microbiology and was conferred a Master of Science of Public Health (MSPH) from the University of Washington, Seattle WA.
