Course details

Overview ?

Introduction

The formal, regulatory, concept of “Good Laboratory Practice” (GLP) originated in the USA in the 1970s because of concerns about the validity of non-clinical safety data submitted to the Food and Drug Administration (FDA) in the context of New Drug Applications (NDA). The inspection of studies and test facilities revealed instances of inadequate planning and incompetent execution of studies, insufficient documentation of methods and results, and even cases of fraud.

Internationally, compliance with GLP is a prerequisite for the mutual acceptance of data; different countries or regulatory authorities accept laboratory studies from other countries provided they comply with the OECD GLP Principles.

Objectives

This workshop is intended to provide analytical chemists and their colleagues in related sciences with concise and convenient summaries of the fundamental data and the practical procedures that to be able to quantify the performance of analytical instruments, in particular with respect to the following:

Estimating uncertainties in instrument
Quantifying and demonstrating performance quality
Identify the dangerous Practices and how to minimize risks associated with them.
To exercise total quality management in producing reliable, consistent, and independent results and on-time to their customers.
To emphasize on equipment calibration and maintenance as part of the quality assurance and quality control procedures.
To increase the awareness of the occupational health and safety in the laboratory environment.
To develop specific techniques for calibration of laboratory equipment.
Statement of uncertainty and compliance.

With an appreciation of the limitations imposed by instrument design, leading to the interplay of the validation and qualification processes within quality assurance systems.

Who should attend?

Laboratory quality/technical managers, Laboratory technicians/supervisors, Assessors of laboratory management systems, Users of calibration and test services, Directors of quality, Improvement of measurement & testing groups

Course outline

Introduction
Laboratory Organization and Personnel
Quality Assurance/Quality control
Occupational health and safety
Hazardous Substances Legislation
The Total Analytical Measurement Process
Measurement as a process - chemical analysis as a system
Ipsative measurements
Norm-referenced measurements
Criterion-reference measurements
Chemical measurement processes
Method calibration (MC)
Preliminary Operations
Chemical analysis as a system
Measurement Process assessment
Validation of a Chemical Measurement Process
Salient Current Trends
Estimation of measurement uncertainty
Type A and Type B evaluation of uncertainty
Sensitivity coefficients
Uncertainty evaluation
Estimation of uncertainty of results
Identification of uncertainty sources
Errors in analytical measurements
Procedures for estimating measurement uncertainty
Decision Environment
Non-numeric data
Laboratory information management system
Non-conformance Report
Technical report writing
Good Laboratory Practice (GLP)

Teaching methodology

The program design includes a high level of interaction between the trainer and the participants. It is built upon the participants input all throughout the program.

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Day 5

Training Methodology

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