Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality

Improving Risk-Based Decision Effectiveness:
Determining The Level Of Formality

ABSTRACT

The Pharmaceutical Regulatory Science Team (PRST) founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches. Since its inception, the PRST has continued to progress research on quality risk management (QRM), knowledge management (KM) operational excellence (OpEx), post-approval change management (PAC, and PAC 1VQ), quality metrics and related topics covered by ICH Quality Guidelines.

Recently the focus of the PRST has been on Risk Based Decision Making (RBDM) and as such has written series of 4 papers on strategies to improve RBDM effectiveness. This, the third of these papers, and it explores formality in decision making within the QRM process

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Valerie Mulholland

Senior Director / Principle Consultant, GMP Services Ltd

Valerie is currently researching a PhD in ‘Demonstrating the Effectiveness of Quality Risk Management in the Pharmaceutical Quality System’ and the focus of the research is risk-based decision making (RBDM).

She is an active member of the global QRM community and has spoken on the topic of RBDM at international industry conferences.

She is a principal consultant with GMP Services, providing compliance & regulatory intelligence – training, auditing, and consultancy – on risk, compliance, and quality systems.

She is Hon Sec of the PDA Irish Chapter and co-hosts a podcast called ‘The Risk Revolution’.

Anne Greene,

Director PRST, Technological University Dublin

Professor Anne Greene heads the Pharmaceutical Regulatory Science Team (PRST) in Technological University Dublin, where she is a senior lecturer and has spearheaded the development of several MSc and BSc Pharmaceutical Programmes. She has supervised industry based executive students to PhD awards in areas of Quality Risk Management, Knowledge Management, Operational Excellence, and PQS. She is currently Head of Part-time Education in the School of Chemical and Biopharmaceutical Sciences in TU Dublin.

Prior to embarking on an academic career, Anne worked at a senior level for several years in the pharmaceutical sector in Validation and Technical Management roles. Anne has a BSc and PhD in Chemistry from University College Dublin.

Anne was a founding member of the PDA Ireland Chapter, where she has held several Officer positions, and is currently a member of the PDA Ireland committee.

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Paper 3: Improving Risk Based Decision Making Effectiveness: Determining The Level Of Formality

Improving Risk-Based Decision Effectiveness: Determining The Level Of Formality

ABSTRACT

Valerie Mulholland

Improving Risk-Based Decision Effectiveness:
Determining The Level Of Formality