Re: ISPE Offers New Training Courses on Technology Transfer
(TAMPA, FL) – ISPE has announced a diverse new training program, Technology Transfer for Active Pharmaceutical Ingredients, for professionals to gain the skills necessary to perform in today’s pharmaceutical industry. Scheduled for October 11-14 in Philadelphia, Pennsylvania, the program includes five courses covering such topics as Technology Transfer for Active Pharmaceutical Ingredients (APIs) and Technology Transfer for Finish Dosage Forms, Oral Solids and Sterile Liquids. The training offers participants a dynamic learning experience based on the ISPE Good Practice Guide: Technology Transfer.
ISPE’s new training course, Technology Transfer for Active Pharmaceutical Ingredients, focuses on the frequent movement of API production from one location to another and the contributing factors, such as new chemical entities that require larger plants with greater capacity to be developed into commercial products, the trend toward outsourcing production of APIs to specialty manufacturers, and pressure on manufacturers to optimize their production in order to reduce costs and schedules. Developed and taught by recognized authorities, the courses are designed for individuals new to the pharmaceutical or biotechnology industry, experienced individuals with new job requirements, or those seeking to expand their basic knowledge and enhance value for their companies.
Technology Transfer for Active Pharmaceutical Ingredients was developed by chemical engineers Stephen Hall and Pierre Le Meur. Hall is director of process technology at AMEC, a global engineering and construction firm. He has worked in manufacturing and chemical development at large operating companies, and recently co-authored a series of articles on API trends that appeared in the ISPE’s Pharmaceutical Engineering magazine. Le Meur is a pharmaceutical engineering consultant in Europe. As a member of the re-write team for ISPE’s Active Pharmaceutical Ingredients Baseline® Guide, he is intimate with cGMPs and practices associated with APIs. Le Meur is a Fellow of the French Pharmaceutical Industry Training Institute.
The Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids course is based on the ISPE Good Practice Guide: Technology Transfer. Using the Guide as a textbook, this course covers technology transfer planning and success criteria for the effective transfer of a finished dosage form, specifically oral solids and sterile liquids. The course also provides a fundamental understanding of analytical methodology to address the challenges faced during technology transfer. It includes exercises to demonstrate the principles presented as well as additional opportunities for delegates to discuss their specific situations.
Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids will be taught by Ashok V. Katdare, PhD, director of project management for Abbott Laboratories. He has more than 20 years of experience in the pharmaceutical industry developing processes and directing programs leading to numerous successful filings and launches. Katdare received the "Hammer Award" from former Vice President Al Gore for expediting the implementation, validation, and approval of Crixivan. He is actively involved with the International Pharmaceutical Excipients Council (IPEC), the American Pharmaceutical Association (APA), and the American Association of Pharmaceutical Scientists (AAPS) and has chaired several committees. Katdare holds a master's degree in pharmaceutical analysis from Bombay University and a PhD in pharmaceutics from the University of Michigan.
The complete lineup of ISPE training courses being offered in Philadelphia includes:
October 11-12
Introduction to the U.S. Pharmaceutical Industry (Including Webinar)
Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids
October 11-13
HVAC for Pharmaceutical Facilities (Including Webinar)
October 13-14
GMP Fundamentals for the Biotechnology Industry (Including Webinar)
Technology Transfer for Active Pharmaceutical Ingredients
Pre-classroom Webinars are offered in conjunction with some classroom sessions to give participants an overview of key concepts needed in preparation for the classroom training. Through these live Internet seminars, participants are able to view the instructor’s presentation in real-time, hear his or her voice, and ask questions.
You also can contact the ISPE Education Department by tel: 1-813/960-2105 or e-mail: customerservice@ispe.org.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 20,000 Life Science professionals in 80 countries. Founded in 1980, ISPE aims to enhance industry practices by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. ISPE Headquarters are based in Tampa, Florida with a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information.
ISPE: Technology Transfer
Date: September 22, 2004
Re: ISPE Offers New Training Courses on Technology Transfer
(TAMPA, FL) – ISPE has announced a diverse new training program, Technology Transfer for Active Pharmaceutical Ingredients, for professionals to gain the skills necessary to perform in today’s pharmaceutical industry. Scheduled for October 11-14 in Philadelphia, Pennsylvania, the program includes five courses covering such topics as Technology Transfer for Active Pharmaceutical Ingredients (APIs) and Technology Transfer for Finish Dosage Forms, Oral Solids and Sterile Liquids. The training offers participants a dynamic learning experience based on the ISPE Good Practice Guide: Technology Transfer.
ISPE’s new training course, Technology Transfer for Active Pharmaceutical Ingredients, focuses on the frequent movement of API production from one location to another and the contributing factors, such as new chemical entities that require larger plants with greater capacity to be developed into commercial products, the trend toward outsourcing production of APIs to specialty manufacturers, and pressure on manufacturers to optimize their production in order to reduce costs and schedules. Developed and taught by recognized authorities, the courses are designed for individuals new to the pharmaceutical or biotechnology industry, experienced individuals with new job requirements, or those seeking to expand their basic knowledge and enhance value for their companies.
Technology Transfer for Active Pharmaceutical Ingredients was developed by chemical engineers Stephen Hall and Pierre Le Meur. Hall is director of process technology at AMEC, a global engineering and construction firm. He has worked in manufacturing and chemical development at large operating companies, and recently co-authored a series of articles on API trends that appeared in the ISPE’s Pharmaceutical Engineering magazine. Le Meur is a pharmaceutical engineering consultant in Europe. As a member of the re-write team for ISPE’s Active Pharmaceutical Ingredients Baseline® Guide, he is intimate with cGMPs and practices associated with APIs. Le Meur is a Fellow of the French Pharmaceutical Industry Training Institute.
The Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids course is based on the ISPE Good Practice Guide: Technology Transfer. Using the Guide as a textbook, this course covers technology transfer planning and success criteria for the effective transfer of a finished dosage form, specifically oral solids and sterile liquids. The course also provides a fundamental understanding of analytical methodology to address the challenges faced during technology transfer. It includes exercises to demonstrate the principles presented as well as additional opportunities for delegates to discuss their specific situations.
Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids will be taught by Ashok V. Katdare, PhD, director of project management for Abbott Laboratories. He has more than 20 years of experience in the pharmaceutical industry developing processes and directing programs leading to numerous successful filings and launches. Katdare received the "Hammer Award" from former Vice President Al Gore for expediting the implementation, validation, and approval of Crixivan. He is actively involved with the International Pharmaceutical Excipients Council (IPEC), the American Pharmaceutical Association (APA), and the American Association of Pharmaceutical Scientists (AAPS) and has chaired several committees. Katdare holds a master's degree in pharmaceutical analysis from Bombay University and a PhD in pharmaceutics from the University of Michigan.
The complete lineup of ISPE training courses being offered in Philadelphia includes:
October 11-12
Introduction to the U.S. Pharmaceutical Industry (Including Webinar)
Technology Transfer for Finished Dosage Forms, Oral Solids, and Sterile Liquids
October 11-13
HVAC for Pharmaceutical Facilities (Including Webinar)
October 13-14
GMP Fundamentals for the Biotechnology Industry (Including Webinar)
Technology Transfer for Active Pharmaceutical Ingredients
Pre-classroom Webinars are offered in conjunction with some classroom sessions to give participants an overview of key concepts needed in preparation for the classroom training. Through these live Internet seminars, participants are able to view the instructor’s presentation in real-time, hear his or her voice, and ask questions.
For additional information about the event, visit http://www.ispe.org/GoToPhiladelphia.
You also can contact the ISPE Education Department by tel: 1-813/960-2105 or e-mail: customerservice@ispe.org.
ISPE, the International Society for Pharmaceutical Engineering, is the Society of choice for more than 20,000 Life Science professionals in 80 countries. Founded in 1980, ISPE aims to enhance industry practices by providing members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. ISPE Headquarters are based in Tampa, Florida with a European office in Brussels, Belgium. Visit www.ispe.org for additional Society news and information.
For more information contact:
Marcela Len, Marketing Coordinator
Tel: 1-813/960-2105
E-mail: mleon@ispe.org ■