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FDA Process Validation Guidance: A Review with Implications
FDA Process Validation Guidance: A Review with Implications
FDA Process Validation Guidance: A Review with Implications for C&Q
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

Speaker Biography

Nuala Calnan, PhD, has over 20 years experience in the pharmaceutical industry including roles at Leo Pharma, Elan, Wyeth BioPharma (Pfizer), PM Group and is currently a member of the Pharmaceutical Science & Regulatory Team at DIT, Ireland. Nuala is also currently a member of the ISPE’s Quality Metrics Pilot team and is leading the Quality Culture sub -team for that group. In addition Nuala co-leads the ISPE/ PQLi Task Team on Knowledge Management.Nuala holds a BSc.(Eng), an MBA and just completed her PhD in Regulatory Science, researching the integration of Excellence, Knowledge & Culture in deliverying enhanced quality outcomes for the patient and has led an Irish Industry research study in this field. Her work has included the development of a Leading Quality Indicator (LQI) metric tool designed to measure changes in workplace behaviours that can influence quality culture, an Excellence Framework for the industry and the recent publication of an e-journal on Knowledge Management in 2014. Nuala has just commence the first Regulatory Science Ireland (RSI) post-doctoral research project to analyse the Product Recall and Quality Defect data at the HPRA, Ireland, with a view to establishing the learnings available to both the regulatory and industry communities.
Discounted member price: 0.00
You could save 100.0%
This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

Approximate Course Duration: 60 minutes (this is a self-paced course)

*NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

Member Price: $ 0.00 / € 0.00
Non Member Price: $ 149.00 / € 122.00