Data Integrity Fundamentals
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
Chinmoy Roy is a seasoned Life Sciences professional. His expertise includes the design, delivery and validation of industry compliant computerized and control systems for pharmaceutical and biotech manufacturing. His focus is on finding lean integrated manufacturing solutions to include Process Analytical Technologies (PAT), Quality by Design (QbD) and Quality Risk Management (QRM). Chinmoy offers over 30 years of US based subject matter expertise in the design, development, QA, validation and CFR 21 Part 11 implementation for automation and computerized systems. As principal Lead Engineer, Chinmoy directed several engineering teams to design, commission, validate and obtain USFDA certification for multimillion dollars worth of computerized control systems. These systems were designed to be compliant with CFR 21 Part 11 requirements and conformant to ISA’s S88 and S95 standards.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description: The biopharmaceutical industry finds itself under increasing pressure to focus on Data Integrity (DI). Auditors require companies to ensure that appropriate DI controls are implemented and appropriately managed throughout the data lifecycle. While industry comes to grips with the complexities of data integrity in their global supply chain, a series of webinars on DI are planned to assist your understanding on how to identify data integrity problems in your company and the steps you need to take to remediate them. Each webinar is designed to address a specific DI issue such as how to establish a corporate DI program, where does DI fit in the data lifecycle, mapping DI to existing predicate rules and how to design for DI during SDLC etc.
Data integrity has been at the forefront of recent news. Regulators are increasingly focusing on data integrity. Audits are unraveling data integrity vulnerabilities arising from data loss during transport and data corruption during data storage and recall.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why Should you Attend: This webinar will demonstrate the fundamental aspects of data integrity and the specifics of data integrity attributes. This understanding is essential to learn about the more complex issues of data integrity.
Objectives of the Presentation: •
Become familiar with the regulatory agencies' perspective of Data Integrity
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Understand the meaning of Data Integrity
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How data integrity manifests itself
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What are the factors that affect Data Integrity
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What are the attributes of Data Integrity
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Review some recently issued 483s and Warning Letters on Data Integrity
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit: QA, QC, Regulators, Engineers, IT personnel, Manufacturers, Laboratory personnel
Live Session - How it works • Username and Password will be sent to you 24 hours prior to the webinar • Presentation handouts in pdf formate will be mailed to you • Login to the session using the username and password provided to you • Get answer to your queries through interactive Q&A sessions via chat • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
Recorded Session How it works • A link will be provided to you upon purchase of the recorded session • Please click on the link to access the session • Presentation handouts in pdf formate will be mailed to you • Get certification of attendance.
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com