India Seminar 2013 on "Good Laboratory Practice Regulations - Introduction and Strategies for Implementation" at Mumbai
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Good Laboratory Practice Regulations -Introduction and Strategies for Implementation" on March 21 and 22 at Mumbai, India.
- San Jose, CA (1888PressRelease) February 15, 2013 - Course Agenda:
Safety testing of medical productsis bound by a myriad of regulations and guidelines. Several rules apply to testing laboratories that study samples derived from test animals or test subjects in clinical studies, too. This two-day course will give participants a detailed understanding of these.
Obviously, laboratory personnel need to have deep and thorough knowledge of the material they test. If any material has to pass an FDA inspection; it has to meet stringent regulatory requirements, for which the basis is good knowledge of the material being tested. This course will help such personnel get an in-depth understanding of the nature of the material they test. The expert, Dr. Kuwahara, will also discuss the types of studies that come under the GLP regulations in detail.
Course Description:
Day 1 - Agenda
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
Day 2 - Agenda
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
Purpose of the seminar
This seminar is designed to help any pharmaceutical worker who performs, supervises or reviews non-clinical studies related to product safety, get a clearer understanding of regulatory requirements set out by the FDA. Workers who perform studies on samples derived from animals or clinical subjects too, are required to know the ins and outs of testing regulatory requirements.
This course will be immensely useful to these kinds of professionals. It is a tool toward facilitating such professionals in gettinga good understanding of these requirements.
About the Speaker:
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. His testing skills were honed in the initial years of his career at the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here, he developed expertise in the testing of blood derivatives, viral and bacterial vaccines.
His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, and gene therapy vectors.
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.
Who will benefit:
a. Directors
b. Managers
c. Supervisors
d. Lead workers in Product Development
e. Regulatory Affairs
f. Quality Assurance and Quality Control
g. 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.
h. Workers in animal care facilities and laboratories that operate under GLP regulations should become familiar with the regulations that apply to their work.
DATE AND VENUE:
March 21 and 22, 2013
Seminar Timings: 9am to 6pm EST
Venue: The Lalit Hotel Sahar Airport, Andheri East.
from 9 am to 6 pm EST at The Lalit Mumbai.
Price -INR 18,000 per delegate for registrations made up to February 15.
INR 20,000 per delegate for registrations made between February 16 and March 17.
Contact Information:
Event Coordinator
Toll free:1800 425 9409 or on080 32014957/080 32473694
Fax:+91 80-2642-1483
Email: customersupport ( @ ) globalcompliancepanel dot com
Website: https://www.globalcompliancepanel.in
GlobalCompliancePanel
NetZealous Services India Pvt. Ltd.
4th Floor, 'A' Block,Brigade Software
Park,Banashankari 2nd stage,
Bangalore-560070, INDIA
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