Best Practices for Effective Pharma Technology Transfer - Webinar CD/Transcript

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Best Practices for Effective Pharma Technology Transfer

The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. It is a significant undertaking and one that needs to be accomplished quickly and efficiently.

In order to be successful several functions at both the sending and receiving site must be employed and fully integrated in all relevant project components.

Join industry expert Susan J. Schniepp as she provides a thorough analysis of the most important do’s and don’ts you need to be aware of as you go through this thorny thicket of commercial development.

This session will focus on the critical areas for a smooth handoff of technology, each of which has enormous legal, practical and scientific ramifications. They are:

  • Transfer from R&D to Clinical Development
  • Transfer from Clinical Development to Commercial
  • Transfer Between Company Facilities
  • Transfer to Contract Manufacturer

You will gain a clear understanding of the following principles, all of which are needed for a successful technology transfer:

  • Robust information exchange
  • Planning and project management
  • Transfer of analytical assays
  • Small-scale verification at receiving site
  • Pre-GMP engineering runs
  • GMP runs
  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Managers
  • Manufacturing directors and supervisors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She has served PDA as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs / Quality Advisory Board, and was awarded PDA’s Distinguished Service Award in 2008.