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 processing equipment and their associated computerized controls. Personnel in supplier/vendor management, engineering, development, quality assurance and validation will also benefit from this program.



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 processing equipment 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 for custom equipment/systems
• 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 allow attendees to learn anecdotally from their peers.

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 processing equipment is critical to compliance with these criteria.  As a result, industry must apply the current regulatory perspective of a life-cycle approach to the implementation and operation of these systems to keep an adequate level of control throughout their time of use.

Initially, the course will discuss the regulatory expectations and other industrial references/standards that will impact your equipment/systems and will follow with a proposed plan and detailed discussion of each phase of the project.  During these sections, attendees will establish the documentation requirements for each phase of the project including specific needs for the computerized control systems. Participants will learn what level of qualification their equipment needs through the application of Impact Concepts (ISPE) and the risk assessment for the process or application in which the equipment will be utilized.

In conclusion, attendees will learn the validation maintenance aspects for these systems focusing on the adequate monitoring and assessment of collected data, internal audits and change control management. During the course, several interactive exercises will be included to provide opportunities for discussion and sharing of experiences.

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