ComplianceOnline, Online Seminar
2025-03-13
Attendees will learn the legal basis of GMP, the regulatory hierarchy (laws, regulations, guidance documents and the role of company procedures), and how to determine what is required for finished products, active ingredients, and investigational drug products. The program will explain how to determine the needed elements of a quality management system, how to decide which procedures are necessary, and how to configure the system for future growth. The program will also cover the FDA inspection process, and introduce participants to key FDA documents that explain the process in detail and facilitate effective preparation and management of FDA inspections. Areas Covered:- Introduction to FDA law, regulation and “GXP” Concepts
- Fundamentals of Good Manufacturing Practice
- Data Integrity: What it is and why it is important to GMP
- Building a GXP Quality Management System
- Selection, qualification and monitoring of contractors
- Phase appropriate GMP considerations – investigational drugs vs commercial
- Preparing for and Managing FDA Inspections
- Enforcement considerations
- Final Q&A
|
|