Mar 11, 2019 | 10:00 AM | Monday

Mon Mar 11, 10:00 AM - Mon Mar 11, 11:30 AM

Online

161 Mission Falls Lane, Suite 216,, Fremont, CA 94539

Community: Upper West Side

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Description

Attendees will be presented with a list of records to identify if they are GMP records.

Event Details

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

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