Implementing a Robust Data Integrity Program- 2019

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 formatStorage mediaEncryptionUser management (access control)Review of the data life cycleHandling of raw dataUnauthorized access
Who Will Benefit:ProductionEngineering & ValidationFacilities / MaintenanceQuality AssuranceRegulatory 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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14@gmail.com