Advanced Analytical Instrumentation for Laboratory

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Advanced Analytical Instrumentation for Laboratory Course
Introduction:
The Analytical Metrology course, spanning five days, covers a wide range of topics essential to the field. Participants will delve into various subjects, including Spectroscopy (HPLC and Spectrophotometers), Optics, and Chemistry Lab Metrology. The course encompasses in-depth discussions on pH, conductivity, viscometry, polarimetry, particulate and biological air sampling, density, titrimetry, and pipettes. Participants will also explore the software used in pipette calibration and other indirect measurements.
Moreover, the course delves into the role of the USP (United States Pharmacopeia) in making technical and quality decisions related to test points, tolerances, and uncertainties. It addresses the question of traceability, both from derived and consensus standards, as well as establishing traceability through natural physical constants. Additionally, the course covers the validation of laboratory equipment, instrument specifications, and ISO/IEC 17025, a standard for testing and calibration laboratories.
Course Objectives:
- Understand the basic operating principles of analytical instrumentation.
- Learn traceability, qualification, and validation principles.
- Establish effective calibration procedures for analytical instruments.
- Build effective interaction with R&D and QA.
- Learn about non-traditional instrument calibration activities for your lab.
- Understand USP's philosophy regarding measurement uncertainty.
- Have a comprehensive look at the latest revision (2005) of the ISO 17025:2005 and its documentation and internal auditing requirements
- Gain critical insight on the interpretation of the requirements of this laboratory standard and receive a detailed review of the accreditation process
- Learn how to design and develop laboratory documents (SOP) and quality manuals and what information they should contain, what writing style is most effective and how to keep your documents and quality manual up to date
- Establish an internal quality audit program as required by ISO 17025:2005, and initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits
- Employ effective techniques of auditing and develop the auditing procedures, scheduling and recording systems needed to sustain the auditing program
- Receive practical instructions on the development, implementation and long-term maintenance of an effective laboratory quality system in compliance with the requirements of ISO 17025:2005
- Go back to your laboratory equipped with an outstanding manual that includes typical SOPs that can be modified and used within your laboratory
Who Should Attend?
This course is suitable for Laboratory Managers, Superintendents, Supervisors, Chemists, Analysts, and Technicians. Further, this workshop will be of great value for Quality Managers, Quality Engineers, Quality Auditors, and Management Representatives.
Course Outlines:
- Simple math models for analytical instruments
- Measurement Uncertainty Analysis for the laboratory
- FDA's role
- United States Pharmacopeia's (USP) philosophy regarding measurement uncertainty
- Calibration philosophies and the future of analytical instruments and calibration requirements
- Analytical instruments terminology and its relationship to calibration
- Chemical standards
- Qualification/Validation of laboratory procedures
- System suitability
- Building quality into a calibration program
- Units of measurement; the key to traceability
- Importance of optics in modern analytical instrumentation and how it can be utilized by the working scientist, engineer and technician
- Overview of ISO/IEC 17025 requirements
- Understanding the difference between quality system registration and accreditation
- Coordinating a quality management system audit against ISO/IEC 17025
- Constructing an audit program and prepare audit checklists
- Learning effective auditing techniques
- Preparing non-compliance statements
- Evaluating the significance of audit findings
- Methods for improving communication skills
- How to report the findings and conclusions
- Developing and implementing corrective action programs
- Evaluating corrective action and understand customer notification requirements
- How to effectively follow-up audit findings to recognize a nonconformity