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Data Integrity for medical device development companies & Part 11 under the FDA QSR

Duration : 60 Minutes

Don Hurd,

Don Hurd has over 35 years of experience in supporting development of applications both in the commercial space and in regulated industries, including defense, telecom, aerospace, and medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and Read more

Data integrity is an integral part of compliance in the life sciences (medical devices, IVDs, pharmaceuticals, etc.).  Numerous recent regulatory actions have been taken due to loss of data integrity.  The growing use of electronic records and electronic signatures compounds the issues related to data integrity.  In this presentation, we’ll discuss data integrity principles, provide an overview of the Part 11 regulation, discuss how data integrity is applied to electronic records, and provide some examples.

Course Objectives:

• Understand basic ALCOA principles

• Baseline understanding of 21 CFR Part 11

• Demonstrate how ALCOA principles are applied within the Part 11 framework

Why Should You Attend:

A loss of data integrity could lead to regulatory delays, findings, or regulatory actions.  Regulatory bodies need assurance that data both on paper and electronic have indisputable integrity.  Adherence to the principles behind the data integrity tenets (ALCOA / ALCOA+) are necessary in the life sciences.  With the growing use of electronic data / records / signatures, companies need to understand how the data integrity principles can be applied electronically.

Course Outline:

• Overview of ALCOA principles

• Overview of 21 CFR Part 11

• Application of ALCOA principles within the Part 11 framework

• Examples

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• Development Engineers 

• Project Managers

• Management

• Document Control Specialists

• Test Engineers

• Lab Personnel

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

Get In Touch

Subject : Data Integrity for medical device development companies & Part 11 under the FDA QSR

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