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Risk Management in Technology Transfer


Shashank Mahashabde (President of Custom Manufacturing Solutions (North America), Neuland Labs)

Location: 119B

Date: Tuesday, April 24

Time: 4:15pm - 5:00pm

Pass Type: Conference Pass, VIP Attendee - Get your pass now!

Track: Drug Manufacturing

Vault Recording: TBD

In today's competitive drug development and manufacturing environment no one can afford to take unnecessary risks or waste valuable time, money, or resources. The linkage of development (Drug/API) and manufacturing is technology transfer, the success of technology transfer lies in the evaluation of risk and the management of risk to complete project on time with predefined quality and cost.

The current topic talks about various aspects of risk management in development and manufacturing of API to meet the objective of "Right-at-First-Time- Technology Transfer”. The formation cross-functional team at the beginning of project is instrumental to have a complete plan covering the tasks of all functions involved in technology transfer.

The session explores:

  • Chemical process development - CPP CQA impact analysis study as per quality- by-design (QbD) principles, and design-of-experiments (DoE) software
  • Analytical method development/Transfer-KSM/intermediates, API – monitoring
  • Equipment Selection/Retrofitting/Procurement – as per suitability as per process requirement or modify the process if need to fit in existing plant
  • Safety Risk Assessment - thermal and process hazards and powder safety characteristics to assess the risk and plan risk mitigation strategy by designing the engineering controls at for safer execution at commercial scale
  • Quality, GMP and RA Risk Assessment – RMs, supply chain etc.
  • Availability of project plan including the review of gap and risk analysis- process, analytical, quality, regulatory
  • Plant Process Validation and regulatory filings