cGMP Training, Current Good Manufacturing Practices Training by Tonex
This cGMP training course provides a comprehensive overview of Current Good Manufacturing Practices (cGMP) to ensure compliance with regulatory standards in pharmaceutical, biotechnology, and medical device industries. Participants will gain a thorough understanding of cGMP principles and how to implement them effectively in their organizations.
Learning Objectives:
- Understand the importance of cGMP in pharmaceutical, biotechnology, and medical device industries.
- Learn the regulatory requirements and guidelines for cGMP compliance.
- Identify key elements of cGMP documentation and recordkeeping.
- Explore best practices for maintaining quality and consistency in manufacturing processes.
- Gain insight into risk management strategies to prevent deviations and non-compliance.
- Develop skills to conduct cGMP audits and inspections effectively.
Audience:
- Quality assurance professionals
- Regulatory affairs specialists
- Manufacturing managers
- Compliance officers
- Pharmacists
- Biotechnologists
- Anyone involved in pharmaceutical, biotechnology, or medical device manufacturing processes
Course Outline:
Module 1: Introduction to cGMP
- Definition of cGMP
- Historical Background
- Importance of cGMP
- Regulatory Agencies and Standards
- Key Principles of cGMP
- Global Harmonization Efforts
Module 2: Regulatory Requirements and Guidelines
- FDA Regulations
- International Regulations (EU, WHO, etc.)
- Compliance Guidelines (ICH, ISO, etc.)
- Documentation Requirements
- Training and Personnel Qualifications
- Handling of Deviations and Non-Conformances
Module 3: Documentation and Recordkeeping
- Batch Records
- Standard Operating Procedures (SOPs)
- Master Production Records (MPRs)
- Change Control Documentation
- Document Control Systems
- Electronic Recordkeeping Systems
Module 4: Quality and Consistency in Manufacturing Processes
- Facility Design and Maintenance
- Equipment Qualification and Calibration
- Raw Material Management
- Process Validation
- Cleaning Validation
- In-process Controls
Module 5: Risk Management Strategies
- Risk Assessment Methods
- Critical Process Parameters (CPPs)
- Failure Mode and Effects Analysis (FMEA)
- Corrective and Preventive Actions (CAPA)
- Continuous Improvement Practices
- Supplier and Vendor Qualification
Module 6: cGMP Audits and Inspections
- Audit Planning and Preparation
- Conducting Internal Audits
- Regulatory Inspection Readiness
- Handling of Inspection Findings
- Follow-up and CAPA Implementation
- Lessons Learned and Continuous Compliance