Implementation Good Laboratory Practices (GLP) is a set of safety regulations for laboratories. When laboratories come up with products that are meant for both humans and animals, they are required to prove through data that their processes and products are safe for the purpose for which they are meant. They should be proven to be safe for humans and the environment. These guidelines, collectively known as GLP’s, are a result of years of evolution of the practices in the field. |
Scientific processes are highly accurate and are of very high importance, because one error, intended or unintended, can lead to serious consequences. The aim of GLP is to prescribe a set of guidelines which minimize and offset damage to humans, animals or the environment. These guidelines will be discussed in full length at a seminar that GlobalCompliancePanel, a leading provider of regulatory and compliance trainings, will be organizing at Mumbai on March 21 and 22.
The seminar: This RAPS-approved seminar, which will earn participants up to 12 RAC points, is about GLP in all its elements. The speaker, Dr. Steven Kuwahara, is founder and Principal of GXP BioTechnology,LLC. This course will present the regulations and guidelines that apply to the safety testing of medical products. It will also discuss the rules as they apply to testing laboratories that study samples derived from test animals or test subjects in clinical studies.
This course is of immense value to any pharmaceutical professional who performs, supervises or reviews non-clinical studies related to product safety. Those professionals who perform studies on samples derived from animals or clinical subjects will find this course very useful. It is also targeted at anyone performing, supervising or reviewing non-clinical safety studies on any type of product that is regulated by the FDA. Other Regulatory Affairs professionals who need to be aware of these regulations and their requirements –namely those who prepare submissions for regulatory agencies –would also find this course useful.
This course seeks to instruct laboratory personnel in the material that they must know or prepare to pass an FDA inspection. The Expert will also discuss the types of studies that come under the GLP regulations. Over two days, the speaker will touch upon important areas pertaining to GLP. These sessions will cover the following:
The speaker: The speaker at this RAPS-approved seminar, which will earn participants up to 12 RAC points, will be Steven Kuwahara. In the field of regulatory compliance training, Steven, as the old saying goes, needs no introduction.
Steven S. Kuwahara, Ph.D., is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. After securing degrees in Biochemistry from Cornell and the University of Wisconsin, Steven started off as an Assistant Professor of Chemistry.
During an impressive career spanning over 30 years, Steven has applied his academic knowledge to quality control in the pharmaceutical industry. Steven has written several papers and book chapters, and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.
Course outline: Lecture 1: Introduction Lecture 2: Part I of the US GLP Regulations Lecture 3: Part 2 of the Regulations Lecture 4: Part 3 of the Regulations Lecture 5: Modifications of the GLP for Non-animal Testing Laboratories Lecture 6: The Animal Welfare Act Lecture 7: European and other GLP Regulations Lecture 8: Types of Non-clinical Studies Subject to the GLP GLP studies: preparation, conduct, documentation
For whom: This seminar is intended to benefit the following types of professionals: o Directors o Managers o Supervisors o Lead workers in Product Development o Regulatory Affairs o Quality Assurance and Quality Control o Workers who will be participating in operations or the supervision of the development of new drugs or devices will benefit from knowing what regulations apply to non-clinical studies. o Workers in animal care facilities and laboratories that operate under GLP regulations should become familiar with the regulations that apply to their work.
Venue: The Lalit, near Sahar Airport, will be the venue for this seminar. This venue is chosen for its proximity to several pharmaceutical companies in Mumbai.
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