Webinar

THE ART OF TECH TRANSFER
Using Gap Analysis to Avoid Regulatory Pitfalls
18 AUG 2020 1:00 to 2:00 PM ET

When you move a product from one location (e.g., lab, manufacturing facility, country) to another, you enter the domain of Technology TransferThe technology transfer process is complex with multiple steps performed in a specific order, requiring a significant resource commitment from many different groups in the organization for activities spanning from a few weeks to many months. All of this calls for comprehensive planning, effective coordination, and first-time-right execution, often on very aggressive timelines. This course will allow you to avoid costly and often irreversible errors, and to be successful, while being in control of schedule and budget.

In this 1-hour free webinar you will:




  • Learn about the industry-proven approach Kymanox uses to help clients of all sizes successfully complete tech transfer projects on schedule and on budget.
  • Discover the key role that gap and comparability assessments play in effective tech transfers.
  • Explore regulatory impact related to tech transfer strategy in biopharma, combination products, and cell & gene therapies

Webinar
THE ART OF TECH TRANSFER
Using Gap Analysis to Avoid Regulatory Pitfalls
18 AUG 2020
1:00 to 2:00 PM ET

When you move a product from one location (e.g., lab, manufacturing facility, country) to another, you enter the domain of Technology TransferThe technology transfer process is complex with multiple steps performed in a specific order, requiring a significant resource commitment from many different groups in the organization for activities spanning from a few weeks to many months. All of this calls for comprehensive planning, effective coordination and first-time-right execution, often on very aggressive timelines. This course will allow you to avoid costly and often irreversible errors and to be successful, while being in control of schedule and budget.

In this 1-hour free webinar you will:




  • Learn about the industry-proven approach Kymanox uses to help clients of all sizes successfully complete tech transfer projects on schedule and on budget.
  • Discover the key role that gap and comparability assessments play in effective tech transfers.
  • Explore regulatory impact related to tech transfer strategy in biopharma, combination products, and cell & gene therapies

WHO SHOULD ATTEND?

This webinar will inform anyone involved in moving analytical assays and/or manufacturing processes internally or externally, in early development, for clinical or commercial manufacturing, including but not limited to professionals from the following functional areas:

  • Process Development
  • Manufacturing Sciences
  • Quality Assurance and Regulatory
  • Quality Control
  • Manufacturing
  • Validation
  • Process Engineering
  • Business Development
  • Project Management
WHO SHOULD ATTEND?

This webinar will inform anyone involved in moving analytical assays and/or manufacturing processes internally or externally, in early development, for clinical or commercial manufacturing, including but not limited to professionals from the following functional areas:

  • Process Development
  • Manufacturing Sciences
  • Quality Assurance and Regulatory
  • Quality Control
  • Manufacturing
  • Validation
  • Process Engineering
  • Business Development
  • Project Management
OUR SUBJECT MATTER EXPERTS

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
OUR SUBJECT MATTER EXPERTS

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
Kymanox
Kymanox Knowledge Bar Logo

*This event is free of charge and open to all interested.
Kymanox Knowledge Bar Logo

*This event is free of charge and open to all interested.