This training 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. It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge.
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
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.
Areas Covered in the Session:
- 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
Principal Consultant ,
Biophia Consulting Inc.
BIOPHARMACEUTICAL R&D EXECUTIVE with a diverse, progressive career. Experience in Drug Substance Development, Formulation Development and Quality Assurance. Cross-functional leadership expertise spans strategic planning, change management, risk management, product strategy, and organizational effectiveness. Demonstrated excellence in managing departments of ~15 R&D personnel. Proven track record in the development, scale-up and technology transfer for commercialization of drug products.
Big believer of stepping out of your comfort zone to add value to those I provide service. Recently, took on a career challenge by leading the development of a new Quality System for the R&D Quality Assurance organization. The formation of the new AbbVie biopharmaceutical company after it split from Abbott Laboratories required the set-up of a new Quality System. This effort significantly improved the organization of the governing policies. In addition new risk management and change management processes were introduced. Through these efforts quality, compliance, and efficiency were significantly improved ensuring that AbbVie meets the patients needs for today and the future.
Contact me if: You need creative yet practical solutions for formulation development, process development, scale-up, or technology transfer. Excellent capabilities in implementing Quality be Design principles for pharmaceutical development. Proven successes in applying business excellence to lead diverse teams needing to develop new efficient development programs. Can support HCP in data analytics.
Specialties: Research and Development, R&D, Small molecule development, Scale-up, Technology transfer, Process Analytical Technology, Quality by Design, Quality Risk Management, Change Management, Regulatory Compliance, Strategic improvement implementation through business excellence principles, Data Analytics, Apply Big Data Analytics for HCP.
- 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