GLP or GMP: A Comparison in Terms and Application for Drugs and Biologics

Why Should You Attend:

The terms GLP and GMP are often confused and used incorrectly. For example, the GMPs do not specifically mention a QA requirement; does that mean that the GLPs should be used as a guide for QA activities? Where can one go for this information? The requirements associated with GLPs and GMPs continue to evolve, as the FDA identifies new issues requiring clarification and control.

As the terms GLP and GMP are critical to those involved in therapeutics, using them correctly is important in maintaining credibility with regulatory health authorities. Additionally, ensuring that the regulations being used are the most up to date version is also critical, as the FDA will expect (and rightfully so), that the latest version is or is being implemented. No one wants to have a discussion with the regulators and be surprised by recent additions to the regulations.

The objective of this seminar is to define the terms, how they were developed, how they are applied and the differences and similarities between the two.

Areas Covered in the Seminar:

• Nomenclature
• The birth, history and evolution of the terms GLP and GMP
• How the GLPs and GMPs came to be an their evolution.
• The major sections of the GLP and GMP regulations: similarities and differences
• A comparison of the two
• Avoiding confusion
• “Flipping on” the GLP or GMP compliance switch: how to do it – or is it possible?

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:

Ms. Rea, is a consultant for QARA Services, LLC, her own business. She retains her affiliation with the BioMedical Regulatory Affairs Masters and Certificate programs of the University of Washington, Department of Pharmacy, including an Assistant Clinical Professor from 2010 -2012. She has held a 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.

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.

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