Global BioPharmaceutical Resources Inc.

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Agenda

Agenda

Overview

An integrated quality systems approach to technology transfer in the Biopharmaceutical and Pharmaceutical industry can lead to a significant improvement in not only cost saving but in minimizing regulatory delays and potential failures. Being first to market is of significant benefit to both the consumer and the company sponsoring the drug. This seminar will focus on "industry best practices" and provide the tools to maximum benefit during the transfer of drugs from site to site and from R&D to production.
In the current regulatory climate for licensing of drugs, information exchange across department lines can be a part of the competitive advantages gained by companies employing a quality risk based systems approach to technology transfer. This seminar draws on current research and case studies to optimize the process of bring drugs to market and transferring drugs to different manufacturing locations.

Who Should Attend

Quality Assurance and Quality control personnel including supervisors, managers and directors. Personnel involved in the technology transfer process, manufacturing staff (managers, supervisors, directors), validation staff, project managers, engineering personnel and R&D staff can learn from this training session.

Industry

Primary industry focus is on pharmaceutical, biotech., biological and vaccines. Companies involved in APIs and subcontractors can also benefit.

Learning Objectives

• Gain an understanding of the scientific bases and process fundamentals to technology transfer (TT)
• Learn how to be first to market using quality systems approach to technology transfer
• Gain insights in partnering with your quality assurance group during the technology transfer process
• Develop a understanding in what regulators look for during TT
• Learn from actual industry case studies, what work and what does not work.

Presenter

Dr. Frank S. Kohn, PhD, NRCM, SCCM, ASCP
FSK ASSOCIATES, INC.
President/ CEO

About Presenter

Frank S. Kohn is president of FSK Associates, Inc. , an international Consulting company providing services to the pharmaceutical, biotechnology, and vaccine industry. Frank worked for Wyeth, where he was Director of Manufacturing at the Sanford, N.C. location. Dr. Kohn has more than thirty years of industry experience working in various technical, quality, and management positions for Schering Plough Corp., Armour Pharmaceutical, Sanofi, and Wyeth Vaccines. He holds graduate degrees in environmental microbiology and operations management. In additional, he has taken additional courses in cGMP regulation and has had several years of direct contact with FDA and various Boards of Health. Frank is a specialist Microbiologist by the National Registry of Microbiology (American Academy of Microbiology) and registered as a specialist Microbiologist by the American Society of Clinical Pathology Board of Registry and the Canadian College of Microbiology. He was on the Publication/Internet Committee of ISPE and chair of ISPE discussion forum on technology transfer. Also, he is chair for the Vaccine AInterest Group for PDA and Section Head for the Biopharm.
Dr. Kohn is the co-author of the book, "Isolation Technology in Pharmaceuticals: Selection, Validation and Use" and presented numerous technical Papers

Registration Fee

Up to & on December 31: $1100
On & After January 1: $1450
Government/Academia: 20% off above pricing

Group Rate: available upon request.