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Parenteral Drug Association Connecting People, Science and Regulation ^®

2019 Annual General Meeting

2019 AGM PRESENTATION

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PDA Ireland Chapter Visual Inspection - Requirements, Practical Implementation and Future Technologies

Visual Inspections Regulatory Trends

By Ann McGee - Presented November 22, 2019

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Achieving Zero Defects for Visible Particles in Injectables

By John Shabushnig - Presented November 22, 2019

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Latest Technology - Deep Learning Solutions for Visual Inspection of Parenterals

By Andrea Sardella - Presented November 22, 2019

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Manual Inspections Capabilites

By Alan McDonagh - Presented November 22, 2019

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Regulatory Approaches for Visual Inspections

By Steven Langille - Presented November 22, 2019

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Considerations for the Design and Use of Container Defects Sets

By Eoghan Greene - Presented November 22, 2019

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Case Study Qualification of an Automatic Inspection Line

By Jonny Parsons - Presented November 22, 2019

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Meeting the Digital Challenge in Pharma

Shane Costigan - My PDA Journey

Shane Costigan, Reagents Genie

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A study into human behaviour in a manufacturing environment using Eye Tracking Technology

Willie Monks and Rebecca Power, MSD Carlow

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Career Roadmap of a Validation Engineer – some of the key competencies required

Donncadh Nagle, Avara, Shannon

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Practical Implementation of QRM - Are We Getting Value?

Risk Based Approach to Auditing

Deirdre Tobin, MSD Brinny

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Demonstrating the Effectiveness of the QRM Program-Measuring Risk Reduction

Tarah Tyson, MSD Carlow

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Demonstrating the Effectiveness of the PQS from a QRM Perspective

Kevin O' Donnell, HPRA

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QRM from Scratch

Martin Blanke, Deloitte Life Sciences

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QRM - A Case Study from Medical Device Manufacturing

Philip Jarvis, CAI

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QRM in CQ and Beyond MQ

Michael Queally, CAI

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Implementation of QRM Model

Amy Norton, Allergan

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Annex 1 (Revision of the EU GMP Guideline)

Contamination Control Strategy

Greg McGurk, Regeneron

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PDA Annex 1 Revision

Ciara Turley, HRPA

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An Assessment on the impact of the revisions made to Annex 1 for the pharmaceutical industry

Sharon O’Grady, QA -Sanofi

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Annex 1- Is your QRM program ready for the challenges posed

Kate Coleman, Pharmalex

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Impact of revised Annex 1 (draft) on Pharmaceutical Water & Steam Systems

Mario Sala Tenna, D.O.C (MASCO Group)

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Please Note: All presentations on this website reflect the opinion of the speakers at a point in time pending the finalized publication of Annex 1.

The Rise of Outsourcing in the Pharma Industry

Outsourced Engineering - Calibration, Maintenance, IT Administration of Systems, Gowning

Kevin Glennon, MSD Ireland

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Outsourcing- Supplier vs. Partner

Paul Hawkins, Avadel Pharmaceuticals

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Contract QP – Release & Change Management

John Henchion, CAI

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APQR

Bob Lynch, Pfizer

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PQRs – A Quality Risk Management Tool

Kevin O'Donnell, HPRA

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Complexity of Managing Post Approval Changes for Global Medicines

Sandra Martin, Pfizer

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Contract Giver-Management of Change AbbVie

Eileen Boyce, AbbVie

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Contract Giver - Management of Change J&J

Eamon Kelly, Janssen Pharmaceutical Companies of Johnson & Johnson

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Case Study A Like for Like change at a CMO

Kevin O'Donnell, HPRA

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Examples of GMP Deficiencies Issued by HPRA in relation to CMOs, Contract Labs

Kevin O'Donnell, HPRA

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Outsourcing - Managing risks and opportunities

Kevin O'Donnell, HPRA

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Quality Culture and Young Professionals

How Culture and Behaviors Drive the Organization Towards Quality and Excellence

Dr. Katrin Winkler, Kempten University of Applied Sciences

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Advances in Aseptic Processing with a Focus on Media Fill Simulations

Aseptic Process Control

Greg McGurk, Regeneron

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Aseptic Processing, Today and the Future

Marco Delgado Rueda, Pharmalex

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Glove Management

Aidan Harrington, DPS Group

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Proficiency Base Progression (PBP) simulation training...

Anthony Gallagher, University of College Cork

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