About
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.
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.
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
- 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)
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.
Training Methodology
Pathways Training and consulting adopts the newest techniques of human resources Training and consulting and, with the following:
- Theoretical lectures are delivered via PowerPoint and visual displays (videos and short films)
- Making scientific evaluation to the trainee (before and after)
- Brainstorming and role-playing
- Using case studies related to the scientific material being delivered and the trainees' work.
- The participants get the scientific and practical material printed and on CDs and Flash memories.
- Preparing records and reports of the participants' attendance and results, with a general evaluation of the training program.
- A group of the best trainers and experts in all fields and specialties professionally prepares the scientific material.
- After finishing the course, the participants get certificates of attendance signed, certified, and issued by pathways Training and consulting.
- Our training programs start at 9:00 o'clock in the morning and end at 2:00 in the afternoon, with snack buffet during the lectures.
- Providing a lunch buffet during the training program period, with organizing a lunch party on the training program final day for taking some photos and certificate awarding.
