cGMP Quality Control Systems (QMS) Certification Course by Tonex
This comprehensive training course delves into the intricacies of cGMP (Current Good Manufacturing Practice) Quality Control Systems (QMS), providing participants with a deep understanding of regulatory requirements, quality control principles, and effective implementation strategies within the pharmaceutical industry.
Learning Objectives:
- Understand the fundamentals of cGMP and its importance in pharmaceutical manufacturing.
- Gain insights into Quality Management Systems (QMS) and their role in ensuring product quality and compliance.
- Learn to interpret regulatory requirements and apply them effectively in quality control processes.
- Acquire skills in designing and implementing robust quality control systems tailored to specific organizational needs.
- Explore best practices for documentation, validation, and risk management in quality control.
- Enhance proficiency in identifying and addressing quality control challenges to maintain product integrity and regulatory compliance.
Audience: This course is designed for professionals working in the pharmaceutical industry involved in quality assurance, quality control, regulatory affairs, manufacturing, compliance, and related fields. It is also beneficial for individuals seeking to enhance their understanding of cGMP requirements and quality control systems.
Course Outline:
Module 1: Introduction to cGMP and Regulatory Framework
- cGMP Overview
- Regulatory Agencies and Guidelines
- Importance of Compliance
- Key Regulatory Requirements
- Evolution of cGMP
- Impact on Pharmaceutical Industry
Module 2: Principles of Quality Management Systems (QMS)
- Understanding QMS Fundamentals
- Documentation and Recordkeeping in QMS
- Roles and Responsibilities in QMS
- Quality Policy and Objectives
- Continuous Improvement in QMS
- Audits and Inspections in QMS
Module 3: Implementing Effective Quality Control Processes
- Quality Control Basics
- Sampling and Testing Procedures
- Control Charts and Statistical Process Control (SPC)
- Non-Conforming Product Management
- Deviation and CAPA (Corrective and Preventive Action)
- Change Control in Quality Control
Module 4: Documentation and Recordkeeping in Quality Control
- Documentation Requirements
- Good Documentation Practices (GDP)
- Data Integrity in Documentation
- Batch Records and Batch Release
- Document Control Procedures
- Electronic Document Management Systems (EDMS)
Module 5: Validation and Verification of Quality Control Systems
- Validation Principles
- Qualification vs. Validation
- Analytical Method Validation
- Equipment Qualification and Validation
- Process Validation
- Cleaning Validation
Module 6: Risk Management in Quality Control
- Risk Assessment in Quality Control
- Risk-Based Approach to Quality Control
- Failure Mode and Effects Analysis (FMEA)
- Risk Mitigation Strategies
- Implementing Risk Management Plans
- Monitoring and Reviewing Risk Management Efforts