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Technology Transfer for Pharmaceutical Processes and Test Methods

Duration : 60 Minutes

Gwendolyn Wise-Blackman,

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method De Read more

Pharmaceutical and biotechnology companies need to transfer technology during drug development. This may occur either during scale-up processes or between test sites. Ensure that your transfer meets your specifications and regulatory agency requirements by approaching technology transfer in a consistent, step-wise, and risk-based manner.

Technology transfer is crucial to conveying information and knowledge between independent sites at a single company or between different workplaces.  Transferring technology is frequently necessary for process development, manufacturing, and analytical testing. Transfer of scientific and process information is necessary since sites used for development may not be able to support full manufacturing or testing in a GMP environment.   Technology used at one site during early development often needs to be transferred to secondary sites or to a separate company or business unit.  Process development may involve innovative techniques or quick changes to methods and processes done on a small scale that now need to be transferred to large scale.  The information on the final process, including specific details for scale-up requires careful implementation to maintain quality.  Manufacturing and analytical testing are frequently not developed at sites that will perform those services.  Initial processes and test methods may change during the final stages prior to technology transfer.  Assuring that the process is clearly understood and appropriately run requires excellent tools in technology transfer.  When information is not clearly presented the process may not follow all steps as required with the possible result of system or product failures.  Identifying and understanding the key issues and pitfalls prior to initiating technology transfer can lead to successful implementation of a process or test method between different sites.

Course Objective:

• Understanding the benefits of controlling the process of technology transfer
• Identifying key components required for a successful transfer
• Implications when going form small scale to large scale
• Documenting the transfer process
• The importance of the site selection process
• Implementing change control after a successful transfer
• Importance of investigating failures

Course Outline:

Topics covered include:

• Background/Introduction to technology transfer
• Understanding the technology transfer process
• Managing risk in technology transfer
• Designing a technology transfer protocol
• SOPS and training
• Validation of the transfer process

What You Get:

•  Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Manufacturing Managers
• Lab Managers
• Development Scientists
• Validation Scientists
• Staff Scientists /Analytical Development Scientists
• Audit and Compliance Personnel / Risk Managers

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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