Length: 2 Days
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Fundamentals of Quality Control and Good Manufacturing Practices (GMP) Training by Tonex

Workshop on cGMP Compliance Through Regular Inspections and Audits of Manufacturing Facilities Certification Course by Tonex

This course provides an in-depth understanding of quality control principles and Good Manufacturing Practices (GMP). Participants will learn how to implement effective quality control systems and ensure compliance with GMP standards to enhance product quality and safety.

Learning Objectives:

  • Understand the principles of quality control and GMP.
  • Develop and implement quality control systems.
  • Ensure compliance with GMP standards.
  • Conduct quality audits and inspections.
  • Implement corrective and preventive actions.
  • Improve product quality and safety.

Audience:

  • Quality control managers
  • Production supervisors
  • Regulatory compliance officers
  • Manufacturing engineers
  • Anyone involved in quality assurance and GMP

Program Modules:

Module 1: Introduction to Quality Control

  • Definition and importance of quality control
  • Key concepts and principles
  • Historical development of quality control
  • Quality control vs. quality assurance
  • Role of quality control in manufacturing
  • Overview of quality control standards

Module 2: Understanding Good Manufacturing Practices (GMP)

  • Definition and scope of GMP
  • Key principles of GMP
  • Regulatory requirements and guidelines
  • GMP documentation and record-keeping
  • Training and competency requirements
  • Role of GMP in product quality and safety

Module 3: Quality Control Systems and Tools

  • Components of a quality control system
  • Statistical process control (SPC)
  • Sampling and inspection methods
  • Quality control charts and graphs
  • Root cause analysis (RCA)
  • Corrective and preventive actions (CAPA)

Module 4: Conducting Quality Audits and Inspections

  • Types of quality audits
  • Planning and conducting audits
  • Audit checklists and protocols
  • Reporting audit findings
  • Implementing audit recommendations
  • Follow-up and continuous improvement

Module 5: Ensuring Compliance with GMP Standards

  • Common GMP violations and how to avoid them
  • Conducting GMP inspections
  • Regulatory compliance strategies
  • Handling non-compliance issues
  • Implementing GMP best practices
  • Case studies on GMP compliance

Module 6: Continuous Improvement in Quality Control

  • Principles of continuous improvement
  • Tools and techniques for process improvement
  • Lean manufacturing and Six Sigma
  • Implementing quality improvement projects
  • Monitoring and measuring improvement results
  • Final project: Develop a quality control and GMP compliance plan

 

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