Netzealous LLC DBA - Compliance4All, Online
2018-02-08
Overview: The APIs covered in this guidance document include new chemical
entities and APIs of biological origin and those created by biotech
processes.
Why should you Attend: This document was created to fulfil the need for specific guidance with
regards to GMPs for APIs. Failure to meet these requirements is a
significant source of observations during regulatory inspections by FDA
or global regulators of manufacturers and/or of sponsors that use
contract manufacturers and the contract manufacturers themselves.
Areas Covered in the Session: Validation of Analytical Procedures, C of As, Stability Monitoring, Expiry
dating Validation Policy, Documentation, Qualification, Process validation,
Validation Approaches, etc. Change Control, Complaints and Recalls, Rejection and Re-use of
Materials
Who Will Benefit: Compliance Professionals Quality Engineer Quality Engineering Manager Validation Engineer Validation Specialist
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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