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Quality Planning and Quality Objectives

WP7 created a guidance document and an e-learning module focusing on the topic of quality planning. 

Quality Planning and Quality Objectives document aims is to introduce a specific process of Quality Management to pharmacovigilance (PV) assessors and any interested parties at National Competent Authorities (NCAs). The document covers basic definitions and introduces the topic through several practical examples from PV collected via an online survey and through written and face-to-face follow-up activities. The purpose is to share experience and disseminate good practice across Member States (MS) and to increase the level of awareness of PV assessors and interested staff on specific areas of quality management. 

What does this document cover?

This document constitutes an item of the quality toolkit that outlines the importance and features of the quality planning process as an integral part of a well-functioning QMS. The document discusses the relationship of business and quality planning and its various levels (strategic and operational). It will be explained how quality objectives – the primary foci of quality plans – may be derived from and related to the quality policy of the NCA and the business planning process. Practical examples and case studies will be provided to demonstrate how PV activities are represented at various levels of the planning process, including the selection and management of objectives related to the quality and business management cycle.

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.

Duration

47 page pdf.

Click here to access this document.


Quality Planning and Quality Objectives e-learning module

The e-learning module is part of a programme of training for pharmacovigilance staff at National Competent Authorities (NCAs) and aims to increase knowledge of a specific process of quality management systems, Quality Planning and Quality Objectives.

Learning objectives

The aims of this course are to enable learners to understand:

 - The concept of planning and the relationship of quality and business planning

 - Various levels of planning from strategy to individual employees

 - The concept of a quality policy and its relationship to quality objectives

 - The concept of quality objectives, and how to define them

 - The relationship of quality objectives to indicators

 - Inputs of the planning process

 - The contents of quality plans

 - The importance of communicating strategies, the quality policy and objectives to staff

What does this e-learning cover?

  1. Introduction
  2. Planning and quality
  3. Levels of planning
  4. Quality policy
  5. Quality objectives
  6. Measurement of quality objectives
  7. The quality planning process
  8. Communication
  9. Module round up

Target audience

The target audience is primarily pharmacovigilance staff working at EU NCAs.

Duration

E-learning: 20 - 22 minutes completion time.

Click here to access this e-learning module.



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