Overview
The purpose of this training is to provide you with an overview of the Technology Transfer. Define technology transfer. Identify New Product transfer process.
Identify elements of the business process framework for managing technology transfers. Explain benefits of technology transfer. Determine elements of a successful technology transfer.
Why should you Attend
- Successful transfer of pharmaceutical products and their processes is critical to the successful launch
- The success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company
- Execution of that transfer is complex involving the interactions of many disciplines across an organization
- 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 Session
- The importance of technology transfer
- Tools and Templates used for technology transfer
- The use of a Product Strategy Review system to review important business aspects in preparation for transfer
- The use of a technical review system to update and review technology knowledge obtained during drug product development
Who Will Benefit
- Process Owners
- Quality Auditors
- Quality Engineers
- Quality Professionals
- Production Engineers
- Production Supervisors
- Senior Quality Managers
- Regulatory Professionals
- Manufacturing Engineers
- Compliance Professionals
- Development Professionals
- Senior Development Managers
Speaker Profile
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
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