Physical Sciences and Mathematics Commons^™

Overview Of The Recent Fda Process Validation Guidance For Medicinal Product Development And Manufacture, Nuala Calnan (Editor)

Conference Papers

This conference paper presents an overview of the recently published FDA Process Validation Guideline for the development and manufacture of medicinal drug products. It discusses the impacts of conducting life cycle based validation activities and highlights the future challenges in meeting the ongoing 'Continued Process Validation' (CPV) expectations of the regulator. It also presents the latest information on the EU draft Process Validation Guidance - due for publication in late 2013 / 2014.

Unlocking The Knowledge: The Key To Delivering The Compliance And Business Benefits Outlined In Ich Q10 For Medicinal Product Manufacture, Nuala Calnan (Editor)

Conference Papers

This paper presents the challenges of delivering a holistic approach to the Pharmaceutical Quality System (Q10) expectations for medicinal product manufacture. It reviews the key findings from the recent ‘Operational Excellence in the Pharmaceutical Industry’ St. Gallen Uni. benchmarking report and explores the theme of 'Knowledge as the Key'. It explores how can we utilise familiar OPEX, Lean/ Six Sigma tools to capture this knowledge and deliver the expectations and opportunities for ICH Q10 and discusses this researchers study in the area of knowledge management and operational excellence.
It also includes a review of both the Regulatory Drivers and recent …

Human Heuristics: Understanding The Impacts For Pharmaceutical Quality Risk Management, Nuala Calnan (Editor)

Conference Papers

This paper addresses the influence of human heuristics (Biases) on the assessment of risk. A core principle underpinning effective Risk Management is the principle that Risk Management explicitly addresses uncertainty i.e., that it explicitly takes account of uncertainty, the nature of that uncertainty, and how it can be addressed. Heuristics are cognitive behaviours which come into play when we make judgements in the presence of uncertainty. How these behaviours are manifested is still the subject of much research, but there is evidence in the literature that heuristics are a source of significant bias and errors in judgement. Awareness of the …

Benchmarking The Pharmaceutical Industry: A Briefing On An Irish Research Study, Nuala Calnan (Editor)

Conference Papers

This paper presents an Irish research study currently being undertaken by the Pharmaceutical Regulatory Science Team at the Dublin Institute of Technology (DIT) into the impact of new pharmaceutical regulatory guidance on the development and manufacture of medicinal drug products.

It launches a Pharmaceutical Industry Benchmarking Questionnaire designed to assess the impact and level of implementation of the ICH Tripartite Quality Guidance Q8, Q9 and Q10.