Introduction to Quality Risk Management

Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. The importance of quality systems has been recognized in the pharmaceutical industry and it is becoming evident that quality risk management is a valuable component of an effective quality system (ICH Q9, 2005).

Personnel working in regulated organisations should be skilled in quality and risk management to ensure these organisations are in compliance with pertinent regulatory requirements.

CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills and experience to perform their assigned duties.

Upcoming

13-05-2019


Introduction to Quality Risk Management

Course Objectives

The goal of this course is to provide a full understanding of the fundamental principles of Quality Risk Management.

Each participant will have gained knowledge about following topics:

  • Fundamentals of risk management
  • Guidelines and references used to construct and perform a good risk assessment
  • Risk management process
  • Effectiveness and usefulness of risk management
  • Various risk assessment approaches
  • How to integrate risk assessment into the system development life cycle
  • Methods for reducing risks
  • Why risk assessments are required and beneficial
  • How to apply the principles of risk management to different needs

Typical Audience

The Basic Quality Risk Management Training course is designed for Business, QA and IT personnel that are new to the regulated environment. It is important, and is also a regulatory requirement, that all individuals working within the life science industry receive GxP related training and are capable of performing their assigned duties.

Course Prerequisites

A basic knowledge of English is required.

Course Delivery

The training is given in a classroom format and is structured to offer flexibility and to cater for participant needs and circumstances by considering prior learning and level of staff experience.

Courses can be given in English or in Dutch. Course material is in English.

Course Venue

The course duration is 1 day.

This course can be given at the client’s site or at CTG.

Course Administration

Pricing

€ 750 per person
€ 695 per person on second subscription for the same company
€ 600 per person on third (or more) subscription for the same company
All prices are VAT excluded; course material, lunch and beverages included.

Cancellation

  • By Participant: If a subscribed course participant is replaced by another participant or if the public course is postponed to a later date, no cancellation costs apply. A participant or a group that fails to attend, or that cancels a course without at least 15 working days written notice prior to the course start, is liable for the full subscription cost.
  • By CTG: CTG reserves the right to cancel a course at any time.

Course Logistics
This classroom course starts promptly at 9 am and is scheduled until 5 pm. All courses are organised at the CTG premises in Diegem (Belgium).
All courses can be given at the client site and are available for groups as well. Please contact us if you wish further information. The standard language of this course is English.

Course Outlines


Fundamentals of Risk Management

  • This module discusses on the concepts and requirements of risk management and provides details on the risk management process.

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Contact

Europe

CTG Belgium NV

Woluwelaan 140A
1831 DIEGEM
Belgium
phone: +32 2 720 51 70
fax: +32 2 725 09 20

North-America

Buffalo, New York

800 Delaware Ave

Buffalo, NY 14209-2094

phone: +1 716 882 8000

fax: +1 716 887 7464