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BEGIN:VEVENT
DTSTART;VALUE=DATE:20260507
DTEND;VALUE=DATE:20260508
TRANSP:TRANSPARENT
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SUMMARY:Data Integrity and Alcoa principles 16th April 2026
DESCRIPTION:Data Integrity and ALCOA Principles\n\nAttendees: Up to 12 people Max\n\nDuration 1 day\n\nVenue: On-site Training in Adhesives Research\n\nProposed Dates: 16th April\n\nProposed Times: 8:30-15:00\n\n \n\nCourse Overview:\n\nThis one-day course provides participants with a comprehensive understanding of data integrity principles and regulatory expectations\, with a focus on the ALCOA framework. Participants will explore the lifecycle of data\, regulatory requirements for electronic records and signatures\, and practical strategies for maintaining compliant data management systems within GxP environments.\n\nThis course will equip participants with the knowledge required to support data integrity compliance throughout the product lifecycle.\n\nIt is our policy to work closely with our clients to ensure that we develop a tailored agenda for each programme so we can add or omit content as advised.\n\n \n\nCourse Content:\n\nModule 1 Data Integrity Fundamentals and the ALCOA Principles\n\nModule 2 Current Legislation requirements\n\nModule 3 Current Challenges facing Regulatory Agencies\n\nModule 4 Regulatory Agencies Inspection Focus\n\nModule 5 Implementing Data Integrity and ALCOA-Based Strategies\n\nModule 6 The way forward\n\n \n\nLearning Outcomes\n\nThe importance and amount of data being generated to ensure product quality and patient safety\, continues to grow and proper controls around that data\, continue to be questioned by Regulatory agencies which are noticing a significant increase in data integrity issues.\n\nRegulatory concerns and warning letters have extended to all areas of the medical device and pharmaceutical businesses including manufacturing\, development\, clinical\, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity\, electronic records and signatures\, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
X-ALT-DESC;FMTTYPE=text/html: \; \;\nData Integrity and ALCOA Principles
\n\nAttendees: Up to 12 people Max
\n\nDuration \;1 day
\n\nVenue: \;On-site Training in Adhesives Research
\n\nProposed Dates: \;16th \;April
\n\nProposed Times: \;8:30-15:00
\n\n \;
\n\nCourse Overview:
\n\nThis one-day course provides participants with a comprehensive understanding of data integrity principles and regulatory expectations\, with a focus on the ALCOA framework. Participants will explore the lifecycle of data\, regulatory requirements for electronic records and signatures\, and practical strategies for maintaining compliant data management systems within GxP environments.
\n\nThis course will equip participants with the knowledge required to support data integrity compliance throughout the product lifecycle.
\n\nIt is our policy to work closely with our clients to ensure that we develop a tailored agenda for each programme so we can add or omit content as advised.
\n\n \;
\n\nCourse Content:
\n\nModule 1 &ndash\; Data Integrity Fundamentals and the ALCOA Principles
\n\nModule 2 &ndash\; Current Legislation requirements
\n\nModule 3 &ndash\; Current Challenges facing Regulatory Agencies
\n\nModule 4 &ndash\; Regulatory Agencies Inspection Focus
\n\nModule 5 &ndash\; Implementing Data Integrity and ALCOA-Based Strategies
\n\nModule 6 \; The way forward
\n\n \;
\n\nLearning Outcomes
\n\nThe importance and amount of data being generated to ensure product quality and patient safety\, continues to grow and proper controls around that data\, continue to be questioned by Regulatory agencies which are noticing a significant increase in data integrity issues.
\n\nRegulatory concerns and warning letters have extended to all areas of the medical device and pharmaceutical businesses including manufacturing\, development\, clinical\, pharmacovigilance and other areas of the product lifecycle. This course will cover data integrity\, electronic records and signatures\, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
\n
LOCATION:on site at Adhesives Global
UID:e.3269.1140
SEQUENCE:3
DTSTAMP:20260706T181303Z
URL:http://members.limerickchamber.ie/events/details/alcoa-1140
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