Procedures for performance

Ways to achieve improved performance

– Improving GMP Performance

Course description

Procedures are an important way of describing how a task is to be performed so personnel can perform the task correctly, consistently, safely, and efficiently. Despite their critical role in making pharma and biopharma products as well as medical devices, writing a clear, easy to follow procedure — and then training people on it — isn’t as simple as it sounds.

This two-day workshop looks at procedures as one of several methods for managing, capturing, and transferring knowledge. Various formats of procedures will be examined and critiqued along with an examination of current regulatory requirements. Using a unique data collection form, participants will collect information that would be included in a procedure and then write (or re-write) a procedure. Participants will have an opportunity of writing (or re-writing) a procedure based on an actual need they have.

Frequently seen “error traps” in procedures will be examined along with ways to reduce procedure-related “human error” performance mistakes.

GMPs require that people be trained on the procedures before using them but there are a variety of methods that can be used, some of which give higher levels of confidence that people can actually perform the task properly. Different procedure training approaches will be discussed and compared. Ways of assessing performance and evaluating the effectiveness of the procedure training will be examined.

Course outline

• Workshop Introduction and Objectives
• Knowledge management and the role of procedures
• Regulatory requirements and expectations regarding procedures and procedure training
• What can we learn from recipes?
• The range of “functional documents
• The procedure writing process
• Human error and procedures
• Writing and reviewing a procedure
• Training on procedures
• Performance support
• Wrap-up and summary

Learning objectives

Use a structured way to write standard operating procedures (SOPs) and provide the appropriate in order to achieve effective, efficient task performance.

Who should attend

Those who write or review procedures and those who provide procedure training, including those in quality, operations, technical services, and maintenance/engineering.