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 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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com