The training will focus on Technology Transfer specific to the following areas: an introduction to TT including where TT is referred to in regulatory guidance documents, types of transfer’s, Receiving site selection, roles and responsibilities, phases of the TT Process, where TT fits in the life cycle of a pharmaceutical product, TT data package, knowledge transfer, key documents and the relationship between the Process Validation Lifecyle and TT.

This course will also look at project management in TT, stage gates, what tools are available to facilitate a TT, application of risk management to TT, key steps for successful transfers, lessons learned and continuous improvement

Elaine Kelleher, Senior Consultant at PharmEng Technology and has over 20 years’ experience in various technical roles for several drug product and drug substance multi-national pharmaceutical companies.  Elaine is an experienced Validation, Engineering and Quality Professional with a demonstrated history of working in the biotechnology and pharmaceutical industries in the areas of Validation (CQV and CSV), Construction Engineering, Quality, Process Engineering, Technology transfer, Manufacturing, Single-use material introduction and qualification (E&L), Data Integrity, Quality Risk Management, Cleaning Validation, Filter Validation, Process Validation (Stage 1, 2 and 3) and Shipping Validation.  Elaine has been involved in the successful start-up and GMP licensing of 7 green-field facilities while in tandem supported the Technology Transfer of key products into each facility.  Elaine is currently project managing the technology transfer of multiple sterile products to CMO’s, is a member of the Combination product project team and also a SME on the new Annex 1 aseptic excellence implementation team.