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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Ireland Chapter Cleaning Validation Event

Apr 25 - Apr 25, 2018 |
Apr 25, 2018 |
National Institute for Bioprocessing Research and Training - NIBRT | Blackrock, Co. Dublin, Ireland
  • Chapter
  • Europe
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Join PDA/BPCI Ireland in Dublin in April to hear about the latest developments in relation to cleaning validation. Present on the day will be representatives from the pharmaceutical industry and experts in the latest cleaning validation advances for pharmaceutical production. Case studies will be presented with practical information on risk and science based approaches that showcase effective implementation of cleaning processes. The agenda will also include a practical demonstration at NIBRT associated with equipment cleaning.

Agenda

08:30 Registration
09:00-09:15 Open and welcome Matt Moran, BPCI
09:15-10:00 Cleaning validation: Introduction, regulations and hot topics, PharmaLex Ireland
10:00-10:45 Case study: Cleaning Optimisation Study - Cleaning of a Compound Vessel in the High Containment Suite at MSD Swords, Fearghal Downey, Hyde Engineering & Consulting Ireland
10:45-11:00 Coffee and Networking Break
11:00-11:45 Industry case study: Biotech Multi Product Cross Contamination Control, Edwin Sutton, Eli Lilly (consultant engineer)
11:45-12:30 Q&A session morning speakers
12:30-13:30 Lunch (Carvery)
13:30-14:30 NIBRT Demo: Vessel & Centrifuge Cleaning
14:30-15:15 Case study: Recent experience of an FDA inspection, Cleaning Validation for a multi-product CMO Biopharmaceutical Facility, Dr. Joe Brady, Lecturer DIT and Consultant Process Development Scientist (Biopharmaceuticals)
15:15-16:00 Industry case study: Small Molecule Cleaning Validation – The Good, The Better and The Holy Grail, Dr. Kevin Lydon, Eli Lilly
16:00-16:15 Networking Break
16:15-17:00 Industry case study: Amgen's bracketing / degradation approach to cleaning validation, Darragh Halpin, Validation Manager, Amgen
17:00-17:30 Q&A session afternoon speakers

Registration

Register at Eventbrite or contact Enda Dempsey for further information, enda.dempsey@ibec.ie

Cost for 1 day event (9:00am - 5:30pm): €210.00

Register Now
https://www.eventbrite.ie/e/pda-bpci-cleaning-validation-forum-tickets-44481996850

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