Advanced Analytical Instrumentation for Laboratory

Introduction

The Analytical Metrology five-day course includes such topics as Spectroscopy (HPLC and Spectrophotometers), Optics, and Chemistry Lab Metrology. The course includes discussions on pH, conductivity, viscometry, polarimetry, particulate and biological air sampling, density, titrimetry, and pipettes. The software used in pipette calibration and other indirect measurements will be explored. The role of the USP in making technical and quality decisions when determining test points, tolerances, and uncertainties will be discussed. The question of traceability from derived and consensus standards as well as establishing “a priori” traceability through natural physical constants will be covered. Validation of laboratory equipment, instrument specifications, and ISO/IEC 17025 will also be covered.

Also, this course is a comprehensive look at the latest revision (2005) of the ISO 17025:2005 and its documentation and internal auditing requirements. You will gain critical insight on the interpretation of the requirements of this laboratory standard and you will also receive a detailed review of the accreditation process.
You will learn how to design and develop laboratory documents and quality manuals. The quality manual will be examined as to its impact on laboratory operations and what purpose it serves. You will learn what information it should contain, what writing style is most effective, and how to keep your documents and quality manual up to date.
This course also gives attendees the knowledge needed to establish an internal quality audit program as required by ISO 17025:2017, and to initiate the sequence of activities involved in scheduling, planning, conducting, reporting on, and closing out internal quality audits. Participants will be able to employ effective techniques of auditing and the ability to develop the auditing procedures, scheduling, and recording systems needed to sustain the program.
Attendees will receive practical instructions on the development, implementation, and long-term maintenance of an effective laboratory quality system.
In addition to the updated knowledge provided to course participants during the course period, each participant will go back to his/her laboratory equipped with an outstanding manual that includes typical SOPs that can be modified and used within the participant’s laboratory. Further, participants will be given videotapes, compressed in one CD that can be used by the participant in training colleagues and subordinates on laboratory safety.

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

Training Methodology

This is an interactive course. There will be open question and answer sessions, regular group exercises and activities, videos, case studies, and presentations on best practice. Participants will have the opportunity to share with the facilitator and other participants on what works well and not so well for them, as well as work on issues from their own organizations. The online course is conducted online using MS-Teams/ClickMeeting.

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 Outline

• 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