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

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

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.