Dr. Joseph Kozikowski will present a series of lectures to government regulators, officials, and industry executives at the KOHI Korean Human Resource Development Institute for Health and Welfare.
NATICK, MA – August 10, 2013 – Clinivation, Inc. announced today that clinivation Founder and CEO Joseph Kozikowski, M.D. will lead an international training module on global good manufacturing practices in the pharmaceutical and biotechnology industries.
As an authority on the development and commercialization of advanced medical technology, Dr. Kozikowski will share his perspectives in a series of training units entitled as follows:
- “Global GMP and the U.S. FDA Approach to cGMPs”
- “U.S. FDA Approach to cGMP Inspection”
- “Recent Developments and Trends in U.S. FDA Inspections”
- “Case Study- Ranbaxy: cGMP Failures in Generic Pharmaceuticals”
The training will address important recent developments and industry best practices, and will include:
- cGMP frameworks for the oversight of pharmaceutical manufacturing quality;
- assessing critical pharmaceutical quality attributes with the U.S. FDA’s new risk-based quality assessment system;
- implementing PAT with supplement and comparability protocol filings;
- systems-based inspection approaches;
- identifying suspect products by review of processing trends and examining reviews performed under 21CFR 211.180(e);
- pattern-of-failure analysis;
- recent U.S. FDA industry guidance on delaying or refusing inspections;
- remote and risk-based “e-inspections”;
- and activities and trends in foreign inspections.
A case study featuring Ranbaxy will describe the timeline of material compliance failures, regulatory actions, and judicial actions that led to the largest financial settlement of criminal fines and penalties in the history of U.S. generic pharmaceuticals. Major cGMP deficiencies described by US FDA inspectors will be presented for discussion and analysis, and numerous instructive examples of deceitful company tactics intended to frustrate the efforts of regulators will be given.
The audience will include Korean government regulators, officials, and industry executives. The training will be held as Training Module 7 on August 23, 2013 at the Education Building, KOHI Korean Human Resource Development Institute for Health and Welfare, Osong, Korea.
Following the presentation, Dr. Kozikowski will be available for discussions and meetings to discuss the topics in greater depth.
Quotes & Commentary:
“It is an honor to have been invited to lead this training module, and I thank Dr. Dong-Yeon Yuk and KOHI for their efforts in arranging this opportunity for international learning,” said clinivation Founder and CEO Joseph Kozikowski, M.D.
KOHI, the Korean Human Resource Development Institute for Health and Welfare, a public institute funded by the Korea Ministry of Health and Welfare, specializes in human resource development that is the main pillar of knowledge and talent management in the 21st century.
Based in the Osong Health Technology Administration Complex, KOHI is a birthplace of Korea’s education on health and welfare and is dedicated to the development of Korea.