Handling of Non-Conformance and Deviations in cGMP Certification Course by Tonex
This course provides comprehensive training on the principles and practices of handling non-conformance and deviations in the context of current Good Manufacturing Practices (cGMP). Participants will learn strategies for identifying, documenting, investigating, and resolving deviations effectively to ensure compliance with regulatory requirements and maintain product quality.
Learning Objectives:
- Understand the regulatory requirements related to handling non-conformance and deviations in cGMP.
- Identify different types of non-conformance and deviations in manufacturing processes.
- Learn effective documentation techniques for recording non-conformances and deviations.
- Gain skills in conducting thorough investigations to determine root causes of deviations.
- Develop strategies for implementing corrective and preventive actions (CAPA) to address deviations.
- Enhance knowledge of best practices for preventing and managing deviations to ensure compliance and product quality.
Audience: This course is designed for professionals working in pharmaceutical, biotechnology, and medical device industries, including quality assurance managers, manufacturing supervisors, compliance officers, and regulatory affairs specialists.
Course Outline:
Module 1: Introduction to Non-Conformance and Deviations in cGMP
- Understanding Non-Conformance and Deviations
- Importance in cGMP Compliance
- Impact on Product Quality and Safety
- Overview of Regulatory Expectations
- Role of Non-Conformance and Deviation Management in Quality Systems
- Introduction to Corrective and Preventive Actions (CAPA)
Module 2: Regulatory Requirements and Guidelines
- Overview of cGMP Regulations
- FDA and EMA Guidelines on Non-Conformance and Deviations
- Documentation Requirements
- Reporting Timelines and Procedures
- Regulatory Inspection Preparedness
- Case Studies on Regulatory Enforcement Actions
Module 3: Types and Classification of Non-Conformance and Deviations
- Major vs. Minor Deviations
- Product vs. Process Deviations
- Systematic vs. Random Deviations
- Critical vs. Non-Critical Deviations
- Examples of Common Non-Conformances
- Case Studies on Different Types of Deviations
Module 4: Documentation and Reporting Procedures
- Importance of Accurate Documentation
- Good Documentation Practices (GDP)
- Deviation Report Formats and Templates
- Responsibilities of Personnel Involved
- Timely Reporting Requirements
- Documentation Review and Approval Processes
Module 5: Root Cause Analysis and Investigation Techniques
- Principles of Root Cause Analysis (RCA)
- Tools and Methods for Investigation
- Fishbone Diagrams (Ishikawa)
- 5 Whys Analysis
- Failure Mode and Effects Analysis (FMEA)
- Trend Analysis and Data Review Techniques
Module 6: Corrective and Preventive Actions (CAPA) Implementation
- Understanding CAPA Concepts
- Relationship Between Deviations and CAPA
- Developing Effective CAPA Plans
- Implementation Strategies and Timelines
- CAPA Effectiveness Monitoring and Verification
- Continuous Improvement Initiatives