Course Objectives

Introduction:

Quality Management Systems in Packaging Materials for Medicinal Products ISO 15378 delivered by Gulf Training and Consultation Center identifies good manufacturing practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products. The realization of GMP principles in production and control of primary packaging materials within organizations is of great importance for the safety of a patient using the medicinal product, because of their direct product contact. The application of GMP for pharmaceutical packaging materials helps ensure that these materials meet the needs and requirements of the pharmaceutical industry. Training course teaches you the process approach, quality management principles and the requirements and benefits of ISO 15378 standard. The essential objective of ISO 15378 training course is to create awareness for participants regarding various basic requirements of the ISO 15378 standard and impart working knowledge on how these requirements can be interpreted to suit the organization’s processes, products, people & customers.

Learning Objectives:

• Understand the structure of ISO 15378.
• Learn importance and benefits of an ISO 15378 Quality Management System
• Understand key requirements, terms and definitions of ISO 15378.
• Learn important concepts such as risk-based thinking, process approach, Plan-Do-Check-Act, and quality management principles.
• Prepare yourself to participate in ISO 15378 implementation process.
• Manage quality and drive continual improvement.
• Take steps to ensure that quality is at the heart of your organization.
• Attract and retain customers by meeting their current and future needs better.
• Learn techniques to create and manage documents and records relevant to ISO 15378 Quality Management System, critical to the products and services delivered and those required to meet customer and regulatory requirements.
• Fill gaps in your professional knowledge and understand the communication requirements
• Understand the documentation and record keeping practices for ISO 15378.
• Understand the inspection and verification techniques to ensure compliance to the requirements of ISO 15378.
• Understand the GMP requirements for printed primary packaging materials.
• Understand documentation and list of procedures to be maintained, and to check them as an internal auditor.

Educational Approach:

• Lecture sessions are illustrated with practical questions and examples.
• Practical exercises include examples and discussions.
• This training is based on both theory and best practices used in ISO 15378 audits.

Why Gulf Training and Consultation Center?

• We have a large pool of experienced and professional auditors that are qualified internationally.
• The competency of our multi-disciplined auditors adds value and credibility to our certificates.
• We have a large pool of experienced and professional auditors that are qualified internationally.
• The competency of our multi-disciplined auditors adds value and credibility to our certificates.

Content

Contact Gulf Training Team to Find Out More Info About the Training Course

Course Target

Who should attend?

• Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 15378 quality management system
• Anyone looking to gain skills and knowledge to improve their career performance
• Quality Managers / Executives / Management System Consultants.
• Engineers and managers (in middle and senior management) who are actively involved in Design, R&D, Manufacturing, Quality Control, Quality Assurance, Material Management and General Management.