Understanding and Implementing a Technology Transfer Process

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.

Learning Objectives:

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

Areas Covered in the 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

Who Will Benefit:

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:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Process owners
• Quality engineers
• Quality auditors
• Development professionals
• Senior development managers

Steven Laurenz
Principal Consultant, BioPhia Consulting Inc

Steven Laurenz has over 25 years of technical leadership experience in product development, process development, technology transfer, and process optimization. He is skilled in taking new products from early laboratory stage to successful manufacturing launch. He is an expert in integrating Quality by Design and risk management into product development. He has proven experience in establishing a Quality System for a R&D Quality Assurance organization.

Steven has headed product development departments at Abbott Laboratories and AbbVie Inc. and held leadership positions in numerous technical consortium.

Steven Laurenz holds an M.S. in Chemical Engineering from the Michigan State University

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