Part 11 Compliance for Your Access Database

e-Conference
February 18, 2009--Presented by Tyson Mew--Register Here

MS Access is the second most popular application for receiving clinical trial data. Databases in Access are simple to set up and easy to use, but like any other software must be configured to meet the FDA's requirements for 21 CFR Part 11 and Computerized Systems Used in Clinical Trials. Before you can use it, the application you design must be validated, yet hundreds of 483s and warning letters are received each year by companies who fail to validate their software or document changes to its design.



Learning Objective
You will learn how to make your MS Access database Part 11 compliant.

What will be covered
This presentation will provide the instructions, materials, and documentation to ensure full compliance with 21 CFR Part 11 for new or existing Access databases. By streamlining these compliance activities, your organization can make better use of these powerful data collection tools and save money that would have been otherwise spend purchasing commercial products. Specifically we will discuss:

[x] Strategies for how to document and validate Access programs.
[x] How to define requirements quickly.
[x] How to document inputs, code, and security settings.
[x] How to add audit trails to any part of the database.
[x] How to properly secure the data and code.
[x] How to implement security settings for multiple users.
[x] Common settings applied to limit user actions.
[x] Managing change control and common mistakes to avoid.
[x] Details on when and where to use electronic signatures.
[x] Advanced techniques for adding electonic signatures, inactivity timeouts, and controls for users and passwords.
[x] Tips for efficient testing for any type of database.
[x] What the FDA looks for during inspections. 

Download Sample Code
You may download sample code and validation documents for your own use.

You will also receive
[X] PowerPoint slides.
[x] An expert speaker.
[x] A chance for QnA.

Audience Suitability
[x] Clinical research professionals who design clinical trials.
[x] Regulatory professionals who report clinical data.
[x] Quality Assurance professionals.
[x] Managers and staff who are responsible for providing valid data.
[x] Statistical professionals who analyze clinical data.
[x] Managers who sign off on clinical trials.

Presenter
Tyson M Mew is President of Ofni Systems, a software provider and Part 11 consulting firm. He has a strong background in software development and computer system validation, and has spoken at many conferences and workshops on Part 11. 

Date, Time, Registration
This 90-minute event will be presented on February 18, 2009 at 11:00 Central time, and will be available OnDemand after that. Event materials will be distributed the day before the e-conference or will be available for download. You will receive 0.15 CEU and a Certificate of Attendance. You may register here!

System Requirements
[x] Personal computer.
[x] Confirmed access to Adobe Connect (test connection by viewing this cartoon.)
[x] Telephone with speakers for live event.
[x] T1 line for OnDemand presentation.