The course will be valuable for those in pharmaceutical, biotechnology and medical device manufacturing who are responsible for, or involved in vendor/contractor selection and controls, design, construction, installation, verification and qualification of facilities, utilities and their associated computerized controls. Personnel in supplier/vendor management, manufacturing, engineering, development, quality assurance and validation will also benefit from the course.



Learning Objectives

Upon completion of this course you will:

• Understand requirements from regulatory agencies and other industry standards in relation to the design, qualification and continuous monitoring of facilities and utilities systems including procedures and documentation needs
• Understand the impact of designing totally automated controls for such systems and the effect on the documentation needs, supplier/vendor involvement and the risk-based approach for their qualification based on the GAMP 5 perspective
• Understand the need to include an adequate design review as a key step on the project management and planning
• Understand the impact of the change control management which must start during the design phase of the project

The course will use interactive workshops and discussions to enable delegates to exchange ideas and experiences, and to learn from each other.

Course Description

Regulatory agencies hold firms responsible for delivering high quality products that meet all established requirements and specifications.  The adequate selection, installation, qualification and continuous monitoring of the facilities and utilities are critical to our compliance with these criteria.  Companies must apply the current industry perspective of a life-cycle approach to the implementation and operation of these systems to keep an adequate level of control throughout their life cycle.

Initially, this course will discuss the regulatory expectations and other industrial references/standards that will impact your systems, and will follow with a proposed project plan and detailed discussion of implementation steps.  During these sections, attendees will establish documentation requirements for each phase of the project including specific needs for computerized control systems.
 
In conclusion, participants will learn validation maintenance aspects for these systems, focusing on adequate monitoring and change control management. During the course, several interactive exercises are included to provide opportunities for discussion and sharing of experiences.

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