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Why Should You Attend?
– Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, management, and transfer of technical and business knowledge along with the development of steps to define the formal transfer of that knowledge from R&D documents and systems to commercial manufacturing documents and systems. This presentation will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation.
Areas Covered in the Seminar or Webinar:
Technology Transfer principles discussed include
· The importance of technology transfer
· The use of a technical review system to update and review technology knowledge obtained during drug product development
· The use of a Product Strategy Review system to review important business aspects in preparation for transfer
· Tools and Templates used for technology transfer
Key Learning Objectives of your Topic:
• The purpose of this training is to provide you with an overview of the Technology Transfer
• At the end of the session, you should be able to:
– Define technology transfer
– Identify elements of the business process framework for managing technology transfers
– Identify New Product transfer process
– Explain benefits of technology transfer
– Determine elements of a successful technology transfer
Who will be benefited?
This course is designed for people tasked with developing, filing, and manufacturing pharmaceutical products especially small molecule oral dosage forms. This includes individuals that have responsibilities for formulation development, scale-up, filing, and commercial manufacture of dosage forms as well as maintaining the high quality of those products. Following personnel will benefit from the course:
Governance systems, technology transfer team, gap analysis, transfer criteria, transfer plan
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Steven Laurenz– Chemical Engineering M.S. – Michigan State University Expertise: Over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. Skilled in taking new products from early laboratory stage to successful manufacturing launch. Expert in integrating Quality by Design and risk management into product development. Experience in establishing a Quality System for a R&D Quality Assurance organization. Experience: Headed product development departments at Abbott Laboratories and AbbVie Inc. Leadership positions in numerous technical consortium. Other: Black Belt certified in Business Excellence and Master Certificate in Applied Statistics