Practices for Active Pharmaceutical Ingredients per ICH Q7

  • Free
  • Published date: December 8, 2017
    • Fremont, California, United States

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

Speaker Profile:
Stephanie Cooke is the President/CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical, biological/biotech products, medical device, combination drug/device and nutraceutical firms.

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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

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