Date :
Place : United States, Fremont
Contact Person:Event Manager
Description:
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: [email protected]Deadline for abstracts/proposals : 9th March 2019
Organized By :Netzealous LLC DBA - Compliance4All
Keynote Speakers :
Venue :Fremont, CA, USA
Check the event website for more details.