ISO 15378 2017 Primary packaging materials for medicinal products - Awareness Course

Description

ISO 15378:2017 primary packaging materials for medicinal products 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. ISO 15378 2017 awareness course teaches you the process approach, quality management principles and the requirements and benefits of ISO 15378 2017 standard. The essential objective of ISO 15378 2017 awareness course is to create awareness for participants regarding various basic requirements of the ISO 15378 2017 standard & impart working knowledge on how these requirements can be interpreted to suit the organization’s processes, products, people & customers.

Who Should Attend?

• Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 15378 2017 quality management system
• Jobseekers interested in understanding the best quality management practices followed by various organisations
• Anyone looking to gain skills and knowledge to improve their career performance 

Key Benefits

• Understand the structure of ISO 15378 2017 standard
• Learn importance and benefits of an ISO 15378 2017 quality management system
• Understand key requirements, terms and definitions of ISO 15378 2017 standard
• 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 2017 standards 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 2017 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
• Understand the communication requirements 
• Understand  the documentation and record keeping practices for ISO 15378 2017 standard
• Understand the inspection and verification techniques to ensure compliance to the requirements of ISO 15378 2017 standard
• Understand the GMP requirements for printed primary packaging materials

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.