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Implementing a Robust Data Integrity Program- 2019

March 11 @ 10:00 am - 11:30 am

$150

Overview:
Attendees will be presented with an overview of the audit trails within an application and the content of each one, Also Attendees will be presented with a list of records to identify if they are GMP records.

Why should you Attend:
The regulatory concern has been responded to by both domestic and foreign governing agencies with the FDA, EMA, MHRA, WHO, and PIC/S all having recently published data integrity standards and guidelines.

Areas Covered in the Session:
File format
Storage media
Encryption
User management (access control)
Review of the data life cycle
Handling of raw data
Unauthorized access

Who Will Benefit:
Production
Engineering & Validation
Facilities / Maintenance
Quality Assurance
Regulatory Affairs

Speaker Profile:
Kelly Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Details

Date:
March 11
Time:
10:00 am - 11:30 am
Cost:
$150
Website:
https://www.compliance4all.com/control/w_product/~product_id=502329LIVE

Other

Organizer Email Address
compliance4all14@gmail.com

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