Mastering GMP: Quality Systems, Risk Management and Inspection Readiness. From Fundamentals to Implementation.
What you'll learn
The fundamental purpose and importance of Good Manufacturing Practices (GMP)
Core GMP principles and global regulatory expectations (FDA, WHO, EU, ICH)
Structure and function of a pharmaceutical quality system
Differences between Quality Assurance (QA) and Quality Control (QC)
Good Documentation Practices (GDP) and the ALCOA+ data integrity framework
Roles, responsibilities, and competency requirements for GMP personnel
How training, hygiene, and professional behavior impact product quality
Key facility, cleanroom, HVAC, and equipment requirements under GMP
Production operations, material handling, traceability, and distribution controls
Principles of process validation and cleaning validation
Strategies to prevent contamination, along with cleaning and sanitation programs
Environmental monitoring methods and how to interpret trends
Quality Risk Management tools and how to perform risk assessments
Deviation handling, root cause analysis, and effective CAPA implementation
How to prepare for and participate in internal audits and regulatory inspections
Requirements
A willingness to learn and develop professional skills in regulated industries
