Course Description

This practical and highly-interactive course includes real-life case studies and exercises where participants will be engaged in a series of interactive small groups and class workshops. Validation and qualification for analytical methods and equipment are required by many regulations, quality standards and company policies. If executed correctly, they can also help to improve the reliability, consistency and accuracy of analytical data. This course guides analyst, laboratory managers and quality assurance managers through the validation and qualification processes in analytical laboratories. The course takes into account most national and international regulations and quality standards. Participants of this course will learn how to speed up their validation and qualification process, thereby avoiding troublesome reworking and gaining confidence for audits and inspections.The validation and qualification procedures presented in this course help to ensure compliance and quality but with minimal extra cost and administrative complexity. The purpose of this course is to answer the key question regarding validation: How much validation is needed and how much is sufficient? The recommendations are complementary rather than contradictory to any standards or official guidelines. They are based mainly on common sense and can be used in cases where information from official guidelines and standards is insufficient for day-to-day work.

TRAINING METHODOLOGY

This interactive training course includes the following training methodologies:

30 % Lectures
20 % Workshops & Work Presentations
20 % Case Studies & Practical Exercises
30 % Videos, Software & Simulators

In an unlikely event, the course instructor may modify the above training methodology for technical reasons.

VIRTUAL TRAINING (IF APPLICABLE)

If this course is delivered online as a Virtual Training, the following limitations will be applicable:

Certificates	:	Only soft copy certificates will be issued
Training Materials	:	Only soft copy materials will be issued
Training Methodology	:	80% theory, 20% practical
Training Program	:	4 hours per day, from 09:30 to 13:30