Trinity College Dublin School of Pharmacy & Pharmaceutical Sciences QP Forum - MacNeill Lecture Theatre, Thursday 10th April 2014 Programme MORNING SESSION: Chairperson, Dr. Thurloch O Críodáin 9.25 a.m. Welcome by Professor Anne Marie Healy, Head of School 9.30 a.m. of the US FDA Safety and Innovation Act (FDASIA) on GMP ‘The impact Compliance’ Dr. Mike Beatrice (President of Validant) 10.15 a.m. Practical advice on and running how to get ‘Product Serialisation’ up Dr. Hugh McMahon (GE Healthcare) & Mr. Eamonn O’Mathuna (ESP) 11.00 a.m. Coffee 11.30 a.m. Parallel sessions for Sterile & Non-Sterile Products Sterile Products MacNeill Theatre Non-Sterile Products Joly Theatre Paul Moody Catherine Neary, ‘Hot Topics’, ‘Hot Topics’, Inspection Issues Inspection Issues Ciara Turley Training Topics Training Topics Led by Frank Hallinan & Led by Paul Blunnie Susan Neenan & Orla Byrne Media Fill Issues Declan Kelly, Alexion Elemental Impurities Paul Blunnie Particulate Metal Checking in David Cassidy, Vincent O’Shaughnessy, Contamination Amgen Tablets & Powders Merck, Swords Quality Risk Thurloch O Críodáin, Powder Flow, Die Fill Csaba Sinka, Management for Novartis and Tableting in a Leicester University Excipients PAT and QbD Context Trends in Inspections Tim Mc Dougall, FDA/MHRA Mylan OR OR QP Quandries* QP Quandries* Led by Stan Led by Ann McGee, O’Neill, The Compliance Group McGee Pharma Int * a number of QPs will present a brief summary of a particular issue which has recently occurred, how it was investigated and the decision making process that was applied. 1.30 p.m. Light Lunch in Concourse AFTERNOON SESSION: Chairperson, Dr. Brendan Griffin 2.15 p.m. GMP & GDP Regulatory Updates Mr. Paul Sexton & Ms. Catherine Neary, Irish Medicines Board 3.00 p.m. for the Quality ‘A new Job Description Professional’ Ms. Jennifer Magnani (Head of Global Quality Genentech USA) 4.00 p.m. Reception in Concourse
Trinity College Dublin School of Pharmacy & Pharmaceutical Sciences QP Forum - MacNeill Lecture Theatre, Thursday 10th April 2014 Programme MORNING SESSION: Chairperson, Dr. Thurloch O Críodáin 9.25 a.m. Welcome by Professor Anne Marie Healy, Head of School 9.30 a.m. ‘The impact of the US FDA Safety and Innovation Act (FDASIA) on GMP Compliance’ Dr. Mike Beatrice (President of Validant) 10.15 a.m. Practical advice on how to get ‘Product Serialisation’ up and running Dr. Hugh McMahon (GE Healthcare) & Mr. Eamonn O’Mathuna (ESP) 11.00 a.m. Coffee 11.30 a.m. Parallel sessions for Sterile & Non-Sterile Products Sterile Products MacNeill Theatre Non-Sterile Products Joly Theatre ‘Hot Topics’, Inspection Issues Paul Moody ‘Hot Topics’, Inspection Issues Catherine Neary, Ciara Turley Training Topics Led by Frank Hallinan & Susan Neenan Training Topics Led by Paul Blunnie & Orla Byrne Media Fill Issues Declan Kelly, Alexion Elemental Impurities Paul Blunnie Particulate Contamination Vincent O’Shaughnessy, Amgen Metal Checking in Tablets & Powders David Cassidy, Merck, Swords Quality Risk Management for Excipients Thurloch O Críodáin, Novartis Powder Flow, Die Fill and Tableting in a PAT and QbD Context Csaba Sinka, Leicester University Trends in Inspections FDA/MHRA Tim Mc Dougall, Mylan OR OR QP Quandries* Led by Stan O’Neill, The Compliance Group QP Quandries* Led by Ann McGee, McGee Pharma Int * a number of QPs will present a brief summary of a particular issue which has recently occurred, how it was investigated and the decision making process that was applied. 1.30 p.m. Light Lunch in Concourse AFTERNOON SESSION: Chairperson, Dr. Brendan Griffin 2.15 p.m. GMP & GDP Regulatory Updates Mr. Paul Sexton & Ms. Catherine Neary, Irish Medicines Board 3.00 p.m. ‘A new Job Description for the Quality Professional’ Ms. Jennifer Magnani (Head of Global Quality Genentech USA) 4.00 p.m. Reception in Concourse
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