Data Integrity and ALCOA Principles
Attendees: Up to 12 people Max
Duration 1 day
Venue: On-site Training in Adhesives Research
Proposed Dates: 16th April
Proposed Times: 8:30-15:00
Course Overview:
This 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.
This course will equip participants with the knowledge required to support data integrity compliance throughout the product lifecycle.
It 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.
Course Content:
Module 1 – Data Integrity Fundamentals and the ALCOA Principles
Module 2 – Current Legislation requirements
Module 3 – Current Challenges facing Regulatory Agencies
Module 4 – Regulatory Agencies Inspection Focus
Module 5 – Implementing Data Integrity and ALCOA-Based Strategies
Module 6 The way forward
Learning Outcomes
The 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.
Regulatory 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.
Thursday Apr 16, 2026
16th april; proposed time 8:30 to 30pm
on site at Adhesives Global
No fee is taken during registration. Your company will be invoiced.
Please note Skillnet discount is available to employees of all nationalities, as long as they are employees of companies registered in the Republic of Ireland. The Company/Employer must pay for the training, and not the individual employee. Skillnet discounts are not available to train employees of Charities, Government-funded or part-government funded organisations.
SIAN MURRAY CARDOSO
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