William N. Weaver, P.E.

Course Outline

This 4-hour course provides an introduction to the creation of a pharmaceutical validation Installation Qualification (protocol). The content of the protocol is explained in detail and attachments are provided for most of the normal qualification contents.

This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.

Learning Objective

At the conclusion of this course, the engineer should be able to:

• Read a proposed Installation Qualification to determine if it is acceptable;
• Create an Installation Qualification for most equipment or systems;
• Review testing included in a protocol to determine if it is adequate;
• Read and understand a protocol prepared by others for his facility;
• Comfortably approve or reject a validation protocol;
• Understand the relationship between types of protocols;
• Understand the concept of "Boundary Limits" as it applies to validation;
• Be able to properly develop a boundary limit for validation;
• Understand the design engineer's responsibility relative to validation;
• Understand the need and types of documents the engineer will be required to provide to the validation group;
• Have a better understanding of the need for labeling various components in the system (valves, equipment, etc.);
• Understand the need to develop accurate P&ID's for the process;
• Understand the need to label all utility systems connected to pharmaceutical equipment or processes;
• Understand the need and responsibilities of each department in the facility relative to the validation effort;
• Understand the approval process for pharmaceutical validation;
• Correctly request documentation from equipment suppliers (manuals, etc.);
• Understand which documents are critical to validation and which are not;
• Understand the concept of Critical and Non-Critical instruments;
• Understand the concept of Critical and Non-Critical utilities;
• Understand the necessity of carefully specifying materials of construction of equipment;
• Have a better understanding of his process based on the analysis required by the validation effort;
• Understand the necessity of developing a working relationship with the validation group;
• Develop an understanding of a GMP (Good Manufacturing Practices) document;
• Appreciate the complexity of the validation effort; and
• Estimate how long the execution of an Installation Qualification will take.
  

Intended Audience

Facilities engineers and management within the pharmaceutical industry.
Engineers in support functions for the pharmaceutical industry.
Individuals who must prepare, read, approve and/or execute protocols.
Engineers developing design documents for the pharmaceutical industry.

Benefits

Enhanced understanding of the validation process

Opens up entry level positions for engineers considering validation as a career.


Course Content

Creating a Pharmaceutical Installation Qualificatiomn (Course Content, Attachments A and B)

Creating a Pharmaceutical Installation Qualificatiomn (Attachments C to I)

Quiz

Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.