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.
Use a structured way to write standard operating procedures (SOPs) and provide the appropriate in order to achieve effective, efficient task performance.
Those who write or review procedures and those who provide procedure training, including those in quality, operations, technical services, and maintenance/engineering.
