2-Day Data Integrity Seminar - FDA/EU Requirements and Implementation (San Diego, USA - June 18-19, 2020)
DUBLIN, Feb. 17, 2020 /PRNewswire/ -- The "Data Integrity: FDA/EU Requirements and Implementation" conference has been added to ResearchAndMarkets.com's offering.
This 2-day course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle.
The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.
Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned.
Day 01 (8:30 AM - 4:30 PM)
09.00 AM: Session Start
Day 1 - Lectures and Workshop Exercises
Module 2: Regulatory expectations
Module 3: Data integrity risk assessment
Module 4: Computerised systems
Module 5: Day 1 conclusions
Day 02 (8:30 AM - 4:30 PM)
Module 7: Computerised system validation
Module 8: Conducting a data integrity audit
Module 9: Managing client audits and regulatory inspections
For more information about this conference visit https://www.researchandmarkets.com/r/eqvn3l
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