Quality Assurance and cGMP Compliance Certification Course by Tonex
This comprehensive training course on Quality Assurance and cGMP (current Good Manufacturing Practices) Compliance provides participants with a deep understanding of quality assurance principles and regulations in the pharmaceutical, biotech, and medical device industries. Through practical examples and case studies, participants will learn how to ensure compliance with cGMP guidelines while maintaining product quality and safety.
Learning Objectives:
Understand the fundamentals of Quality Assurance (QA) in regulated industries.
Gain insight into cGMP regulations and their importance in ensuring product quality and safety.
Learn strategies for implementing effective QA systems and processes.
Identify common challenges in maintaining cGMP compliance and develop solutions.
Explore best practices for auditing and inspection readiness.
Acquire knowledge of risk management techniques to mitigate quality-related issues.
Audience: Professionals working in pharmaceutical, biotech, or medical device industries involved in quality assurance, regulatory affairs, compliance, manufacturing, or auditing roles. This course is suitable for both newcomers and experienced individuals seeking to enhance their understanding of QA and cGMP compliance.
Course Outline:
Module 1: Introduction to Quality Assurance and cGMP Compliance
Importance of Quality Assurance
Evolution of cGMP Regulations
Role of Regulatory Agencies
Overview of Quality Systems
Key Principles of cGMP
Integration of Quality Assurance and cGMP Compliance
Module 2: Overview of cGMP Regulations and Guidelines
Regulatory Framework
International Standards (ICH, ISO)
FDA cGMP Regulations
European Medicines Agency (EMA) Guidelines
cGMP Requirements for Biotech Products
cGMP Requirements for Medical Devices
Module 3: Establishing Effective QA Systems and Processes
Quality Management Systems (QMS)
Documentation and Record-Keeping
Change Control Procedures
Training and Personnel Qualification
Supplier Management
Continuous Improvement Initiatives
Module 4: Challenges in Maintaining cGMP Compliance