Tech Transfer During Critical Times

$595.00

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

Attendance Limited

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.

Workshop Outline
  • 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
$595.00

25 in stock

SKU: WBR-0805 Category: