Results from the PDA survey on Technology Transfer have now been published documenting key highlights and findings from the participant response! This publication which was co-authored by one of CAI's principal consultants, Beth Haas, can be found in the PDA Bookstore. Learn more about Beth below.
This survey report assesses the types of technology transfers being performed, the tools and processes used in those transfers, the use of multidisciplinary teams, the potential regulatory complications, and the impact of emerging technologies. It was broad in scope covering transfer of all pharmaceutical and biopharmaceutical products/processes with the goal to investigate current practices and learn how companies conduct technology transfers including the process, knowledge and risk management, documentation, and business strategies. More than 250 industry professionals from around the world completed the survey. Respondents are experts involved in technology transfer activities within their current companies who possess a strong understanding of their companies’ technology transfer procedures and/or activities. Take a look to learn more about what is happening in the PMT Business Area related to Technology Transfer.
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About the Author:
Beth has successfully commercialized products across a variety of industries. As a TT program manager, Beth uses her skills in product development, process engineering and risk management to lead global cross-functional teams with energy and focus on the business goals. In her work, Beth has written and reviewed Drug Master Files for both U.S and EU regulated markets and has performed process, analytical, equipment, and cleaning validations/qualifications resulting in multiple successful FDA inspections and approvals. One of Beth’s strengths is performing process gap analysis, process mapping, and risk assessments to define opportunities for improvement. Beth is also proficient in Quality Risk Management, LEAN techniques, quality systems, product economics, and supply chain analysis.