This course will cover key learning approaches to the Art of Technology Transfer. We will take a look at an overall perspective on Technology Transfer from an industry lens, highlight key learned success factors, and discuss a Pharmaceutical Development approach that captures critical information for Technology Transfer along the way.
We will also explore the important aspects of the Knowledge Management process and its impact on Technology Transfer. Finally, the session will outline how to build a Technology Transfer framework that delivers a successful and repeatable process across the drug development lifecycle.
It falls on Leadership and Scientific teams to master this art and build an internal framework integrated into the development process. This session will provide the tools and strategic understanding needed to execute robust, efficient, and repeatable transfers across functions and sites.
We will also explore the important aspects of the Knowledge Management process and its impact on Technology Transfer. Finally, the session will outline how to build a Technology Transfer framework that delivers a successful and repeatable process across the drug development lifecycle.
Why You Should Attend
In today’s global drug development environment, conducting Technology Transfer successfully and repeatedly is vital to organizational health. Yet current regulatory guidance on this topic remains minimal.It falls on Leadership and Scientific teams to master this art and build an internal framework integrated into the development process. This session will provide the tools and strategic understanding needed to execute robust, efficient, and repeatable transfers across functions and sites.
Course Content
- Perspective
- Success Factors
- Pharmaceutical Development
- QTPP (Quality Target Product Profile)
- Critical Quality Attributes (CQAs)
- Risk Assessment
- Control Strategy
- Quality by Design (QbD)
- Materials and Components
- Process
- Methods
- Knowledge Management
- Critical Concepts
- Data Systems
- Technology Transfer Process
- Definitions
- Keys to Successful Technology Transfer
- Technology Transfer Framework
- Pre-transfer Gap Analysis and Risk Assessment
- Project Plan
- Protocol(s)
- Report(s)
- Wrap-Up
- References
- Q&A
Speaker
Scott Thatcher is a 20+ year veteran of the pharma/biopharma industry. He is a published author in analytical chemistry and photostability studies. He has contributed to the CMC development and launch of multiple drug programs in different delivery systems. He has executed stress studies for the development and validation of 100s of analytical methods. He is an expert in the interpretation of the ICH Q1B guideline and has contributed to multiple regulatory submissions that met regulatory requirements and subsequent agency approval.Who Should Attend
- Leadership / Managers
- Analytical Scientists
- Formulation Scientists
- Regulatory Scientists
- Quality Assurance Departments
- Document Control Specialists
- Information Technology Departments
- Engineering Departments
