SAFETY TESTING OF MEDICAL PRODUCTSIS BOUND BY A MY 2013 - 2-day In-person Seminar on “Good Laboratory Practice Regulations - Introduction and Strategies for Implementation” at Mumbai

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Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Helth

Deadline: March 20, 2013 | Date: March 21, 2013-March 22, 2013

Venue/Country: Mumbai, India

Updated: 2013-01-28 13:34:24 (GMT+9)

Call For Papers - CFP

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.

Dr. Steven Kuwahara, 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, will be the speaker at this seminar.The venue will be announced soon.

This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

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: customersupportglobalcompliancepanel.com

Website: https://www.globalcompliancepanel.in

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