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DTSTART:20220101T000000
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DTSTART;TZID=UTC:20221020T090000
DTEND;TZID=UTC:20221020T170000
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SUMMARY:PHSS Annex 1 Discussion forum
DESCRIPTION:  \nDiscussion forum moderators: \nDi Morris PHSS Co-Chair\, James Drinkwater (Ex-Chairman\, honorary member) \n\nObjectives of the Annex 1 discussion forum and intended outcomes\nOverview of key updates in Annex 1 from version v12 that was the subject of a targeted consultation process with PHSS as one of the (12) EC appointed Targeted commenting platforms through to the final publication on 25 August 2022 that goes a long way to addressing industry concerns\, but still issues of clarity remain.\nInsight to how the discussion forum will be managed.\n\nImportant Quality related concepts that are fundamental to the revised Annex 1 \n\nThe paradigm shifts in GMP regulations to Risk based\, holistic and proactive methodologies and international relevance of Annex 1.\n\n\nRisked based with QRM as a fundamental principle\n\n\nHolistic considering collective effectiveness of control measure across interrelated areas and operations.\n\n\nProactive with data-based knowledge\, trending and reviews that drive improvements over the product Life cycle (ICHQ12).\n\nDiscussion sessions \n\nContamination Control Strategy (CCS) insight to expectations and PHSS guidance to assist preparation.\n\nBreak for refreshments \n\nSession 1: Annex 1 sections 1; Scope\, 2; Principle\, 3; Pharmaceutical Quality System (PQS).\n\nBreak for Lunch \n\nSession 2: Annex 1 sections 4; Premises\, 5; Equipment\, 6; Utilities\n\nShort break \n\nSession 3: Annex 1 sections 7: personnel\, 8: Production and specific technologies\n\nAfternoon Break \n\nSession 4: Annex 1 sections 9; Environmental and process monitoring\, 10: Quality Control\, Glossary\n\n Thanks\, closing statement and discussion close.
URL:http://52.56.119.59/event/phss-annex-1-discussion-forum/
LOCATION:London Heathrow Marriott Hotel\, Bath Road Heathrow Airport\, Hayes\, London\, UB3 5AN\, United Kingdom
CATEGORIES:Conference
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