GMPs for All Phases – Ensuring GMP Compliance – 2018 Workshop by Ex-FDA Official

Date	Oct 18, 2018
Time	10:00 PM EDT
Cost	$107360.00
Online

This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.Good Manufacturing Practices are the foundation for all drug & biologic products intended to be dosed to humans. Sponsors are legally required to follow GMPs in their manufacturing processes. It’s recognized that early clinical trials involve a small number of subjects and require a small amount of product. And, at this early stage, could present undue investment burden for sponsors to comply fully with all GMPs. Therefore, provisions have been made to use a risk-based approach across phases of development. This workshop will provide details for you to ensure GMP compliance.

Who Should Attend:
Directors, VP’s, Managers, Supervisors in:

• Quality Assurance Departments

• Quality Control Departments

• Manufacturing Departments

• Regulatory Affairs Departments

• Production Departments

• Documentation Departments