Lisa Bello's Professional Portfolio

This procedure documents the process for training personnel performing tasks within the Quality Management System (QMS).

This work instruction provides information on how to comply with Good Documentation Practices (GDocP).

Form to capture training that takes place on the job (OTJ) or outside of the learning management system (LMS).

Template for Visitor Safety & Good Manufacturing Practice (GMP) Guidelines.

Training plan to be used for employees who will be working in the pharmaceutical quality management system in a document control capacity. 

Quality plan defining a QMS remediation project: outlining objectives, processes, roles, resources, and methods. 

This process control plan aligns QMS training activities with applicable regulatory requirements and provides a response plan for deviations.

Process flow map for QMS training management. Defines flow, roles, purpose, scope, inputs, outputs, exceptions, points of control, and measuring conventions.

Simple Gantt chart for tracking a QMS project. Provides a visual display of the project steps and timeline.  

Gap assessment for the consolidation and alignment four separate Quality Management Systems (QMS) where the host QMS is currently certified to ISO 13485 (medical device standard) but will also need to cover ISO 9001 (general standard).

This stakeholder assessment focuses on the affected parties and their involvement with a Quality Management System (QMS). It includes the stakeholders, their level of interest & influence, and associated risks & opportunities.

This JHA , also known as a Job Safety Assessment (JSA), identifies potential risks and proactive actions to be taken to help reduce safety risks in the small components picking process.