FDA Process Validation Guidance: A Review with Implications for Commissioning & Qualification

A review of the recent changes in the FDA's thinking on lifecycle based process validation as published in their long awaited update to the 1987 PV guidance. This presentation provides an overview of the key elements of the draft and looks in particular at the role that verification/CQ can play in supporting these outcomes. At the conclusion of this session, participants will be able to:

  • Understand the current FDA thinking on lifecycle based process validation
  • Understand the implications for the process design and process qualification phases of the lifecycle
  • Prepare your organization with the skills expected to support the new requirements necessary for continued process verification
Nuala F. Calnan, PhD
Senior Associate
Biopharm Excel Ltd

Nuala Calnan, PhD has over 20 years’ experience in the pharmaceutical industry and is currently an adjunct Research Fellow with the Pharmaceutical Regulatory Science Team at DIT, Ireland, where she leads a number of patient focused regulatory science research projects at Masters and PhD level. Nuala’s focus is on the integration of Knowledge Excellence, Operational Excellence, & Cultural Excellence in delivering enhanced quality outcomes for the patient and has led a recent Irish Industry research study in this field examining the Product Recall and Quality Defect data at the Irish medicines regulator, HPRA. She is currently a member of the St. Gallen University led team who were awarded a one-year research grant by FDA examining the role of Quality Metrics in determining risk-based inspection planning. Nuala also works closely with industry in the areas of Quality Excellence, Data Integrity and Quality Culture development. Nuala co-leads the ISPE Quality Culture Team and the ISPE/PQLI Task Team on Knowledge Management.

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