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X-ORIGINAL-URL:https://www.novatekeurope.com
X-WR-CALDESC:Events for Novatek
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DTSTART:20220101T000000
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BEGIN:VEVENT
DTSTART;TZID=UTC:20221020T090000
DTEND;TZID=UTC:20221020T170000
DTSTAMP:20260821T183618
CREATED:20221012T085733Z
LAST-MODIFIED:20221019T020323Z
UID:2069-1666256400-1666285200@www.novatekeurope.com
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:https://www.novatekeurope.com/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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BEGIN:VEVENT
DTSTART;VALUE=DATE:20220801
DTEND;VALUE=DATE:20220804
DTSTAMP:20260821T183618
CREATED:20210404T034056Z
LAST-MODIFIED:20221012T084727Z
UID:261-1659312000-1659571199@www.novatekeurope.com
SUMMARY:SPEAKER: 2022 PDA Annual Meeting
DESCRIPTION:Level Up: Agility in the New Normal \nThis Conference will focus on the theme to Level Up: Agility in the New Normal! We will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. \nASEPTIC PROCESSING & STERILIZATION SPEAKER:\nDAY 2: Tuesday April 5\, 2022 \nStrategies for Total Contamination Control in an Aseptic Environment\n \nSheba Zaman\, Head of Product Specialists and Training Services\, Novatek \nCome also see us at BOOTH 406 in the Exhibitor Hall!
URL:https://www.novatekeurope.com/event/speaker-2022-pda-annual-meeting/
LOCATION:Hyatt Regency Dallas
CATEGORIES:Conference
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