cGMP for Quality Assurance Analysts Certification Course by Tonex
This comprehensive training course equips Quality Assurance Analysts with the necessary knowledge and skills to navigate cGMP (Current Good Manufacturing Practice) regulations effectively. Participants will delve into the critical aspects of cGMP compliance to ensure product quality and regulatory adherence in pharmaceutical and related industries.
Learning Objectives:
- Understand the fundamentals of cGMP regulations.
- Identify key components of cGMP compliance in manufacturing processes.
- Learn to implement quality assurance measures to ensure regulatory compliance.
- Gain insight into documentation practices essential for cGMP compliance.
- Familiarize with risk assessment techniques in relation to cGMP.
- Develop strategies for maintaining and improving cGMP compliance within an organization.
Audience: Quality Assurance Analysts, Quality Control Personnel, Regulatory Affairs Professionals, Compliance Officers, and individuals involved in pharmaceutical manufacturing processes seeking to enhance their understanding of cGMP regulations.
Course Outline:
Module 1: Introduction to cGMP Regulations
- Overview of cGMP
- Historical Background
- Regulatory Agencies and Authorities
- Importance of cGMP in Pharmaceutical Industry
- Global Harmonization Efforts
- Recent Developments and Updates
Module 2: Key Principles and Concepts of cGMP Compliance
- Quality Management Systems (QMS)
- Personnel Training and Qualifications
- Facility and Equipment Design and Maintenance
- Process Validation
- Raw Material Control
- Product Packaging and Labeling Requirements
Module 3: Documentation Requirements and Best Practices
- Good Documentation Practices (GDP)
- Batch Records and Batch Documentation
- Standard Operating Procedures (SOPs)
- Change Control Procedures
- Record Retention and Archiving
- Electronic Data Integrity
Module 4: Quality Assurance Strategies for cGMP Compliance
- Quality Risk Management (QRM)
- Audits and Inspections
- Corrective and Preventive Actions (CAPA)
- Deviation Management
- Complaint Handling
- Supplier Qualification and Management
Module 5: Risk Assessment in cGMP Processes
- Hazard Analysis and Critical Control Points (HACCP)
- Failure Mode and Effects Analysis (FMEA)
- Risk Assessment Tools and Techniques
- Impact of Human Factors on cGMP Compliance
- Risk Mitigation Strategies
- Regulatory Expectations for Risk Assessment
Module 6: Continuous Improvement and Maintenance of cGMP Compliance
- Continuous Process Verification (CPV)
- Performance Metrics and Key Performance Indicators (KPIs)
- Management Review Processes
- Training and Development Programs
- Incorporating Feedback and Lessons Learned
- Adaptation to Regulatory Changes and Emerging Trends