ISO 15378 Awareness Training

Introduction to ISO 15378 (1 hour)

• Overview of ISO 15378: What is it and why is it important?
• Historical background and development of ISO 15378
• Key concepts and principles of ISO 15378
• Benefits of implementing ISO 15378

Understanding the Pharmaceutical Quality Management System (1 hour)

• Introduction to the concept of a Quality Management System (QMS)
• Overview of the pharmaceutical industry and its quality requirements
• Role of ISO 15378 in ensuring quality in the pharmaceutical supply chain
• Integration of ISO 15378 with other quality standards (e.g., ISO 9001)

Scope and Requirements of ISO 15378 (2 hours)

• Scope and applicability of ISO 15378
• Understanding the key requirements of ISO 15378
• Documentation and record-keeping requirements
• Roles and responsibilities within the pharmaceutical organization

Implementing ISO 15378 (2 hours)

• Steps for implementing ISO 15378 within an organization
• Gap analysis and identifying areas of improvement
• Establishing a pharmaceutical quality management system
• Integration of ISO 15378 requirements into existing processes

Auditing and Certification (1 hour)

• Overview of the auditing process for ISO 15378
• Internal audits and management reviews
• Selection of an accredited certification body
• Achieving and maintaining ISO 15378 certification

Case Studies and Best Practices (1 hour)

• Real-life case studies of organizations implementing ISO 15378
• Lessons learned and challenges faced during implementation
• Best practices for successful ISO 15378 implementation
• Q&A session and open discussion

Note: The course outline provided is a general guideline and can be tailored or adjusted to meet specific training objectives or time constraints.