Tech Transfer During Critical Times
28 Oct 2020 | 9 AM – 4 PM ET
When you move a product from one location (e.g., lab, manufacturing facility, country) to another, you enter the domain of Technology Transfer. In this extensive one-day program for professionals in pharmaceutical, biologics, vaccine, cell and gene therapies, and combination product industries you will:
- Examine technology transfer principles including what key steps to take and in what order
- Learn about the industry-proven approach Kymanox uses to help clients of all sizes successfully complete tech transfer projects on schedule and on budget
- Explore what tools to create and how to use them effectively during tech transfers
All attendees receive a certificate of completion.
Our Subject Matter Experts Include:
Stephen M. Perry, CEO and Founder
- Industry-recognized instructor in multiple subject areas, including technology transfer
- 20+ years experience in process engineering, QA, and regulatory initiatives related to biopharma and combination products, including successful filings and responses to the FDA
Brittany Alston, Sr. Process Engineer
- 10+ years life science experience, skilled in process validation, technology transfer, process development, and purification chromatography
- Experience with biopharma and solid dose tech transfer and scale up, including comparability assessments
Why You Should Attend
The technology transfer process is complex with multiple steps performed in a specific order, requiring a significant resource commitment from many different groups at both the transferring, and the receiving organizations, for activities often spanning many months. A successful technology transfer requires comprehensive planning, effective coordination and first-time-right execution, in order to meet, often aggressive, timelines.
By following the procedures and using the tools explained at this course, you will gain the knowledge and tools necessary for a successful program, while being in control of the schedule and budget and avoiding costly and often irreversible errors.
- Introduction to Technology Transfer
Methodology and approach to satisfying regulatory requirements of the transfer of medicinal products.
- Decision to Transfer & Project Initiation
Develop the business case, select a receiving site using assessment tools, establish the project team and key project objectives and timelines.
- Information Exchange & Evaluation
Exchange information on the manufacture of the product at the sending site and the receiving site capabilities.
- Planning Tech Transfer Activities
Develop planning and execution documents for the overall tech transfer and specific workstreams, based on assessment tools.
- Transfer of Materials and Assays
Methodology material transfer and analytical assay transfer, qualification, and/or verification.
- Process Transfer and Transfer Verification
Methodology for the process transfer, detailing development activities for a biopharmaceutical product, and verifying technology transfer at scale.
- Transfer Confirmation and Sustainability
Product manufacture in the cGMP environment, assessing the success of the technology transfer, and developing sustainability programs.
- Technology Transfer Documentation & Project Closure
Technology Transfer documentation and regulatory requirements and project closure activities.
After The Workshop You Will Be Able To…
- Set-up a team of professionals essential for the success of technology transfer
- Assess feasibility, business, and regulatory impact
- Identify necessary actions and create detailed assay and process transfer plans
- Properly monitor, evaluate progress, and proactively manage the transfer
- Define criteria and document the success of the technology transfer
- Defend the rationale for and the outcome of the transfer in front of regulatory bodies
Attend And You Will Receive…
- Multiple lectures on the methodology and specific activities for successful technology transfer
- Examples of real-life industry cases
- Detailed list of documents and tools required for successful technology transfer
- Access to instructors with first-hand technology transfer experience
- Certificate of completion