Methods Development, Validation Procedures, and Conformity Assessment in the Analytical Laboratory

What You Will Learn
Implementation of Quality Assurance principles and techniques is becoming increasingly important in the analytical, R&D, and quality control laboratories. This short course is addresses the key elements of these principles and techniques including different approaches for development, optimization, and validation of methodologies. The important fundamentals will be thoroughly covered. Technique specific considerations will be explored using example applications in HPLC, HPCE, etc., and case histories from industrial experience. Validation procedures, including documentation requirements for regulatory conformity, will be explained.

Who Should Attend
The course will be useful for practicing analytical and QA professionals and for laboratory technicians.

Requirements of regulatory submissions
Good Laboratory Practices (GLP)
Good Manufacturing Practices (GMP)
Laboratory accreditation
Methods development and optimization
Quality Control and Quality Assurance
Analytic Data Integrity
Statistical Treatment of Analytical Data
Validation procedures
Documentation for regulatory conformance

Dr. Shib Mookherjea is currently managing the Analytical R&D Group and directing Quality Control at Troy Corporation. He has played a key role in Troy's ISO 9000 efforts from their outset. He has over 20 years of experience in R&D, Quality Assurance, and Quality Management in the pharmaceutical and chemical industries at companies including Johnson & Johnson, Colgate-Palmolive, and BASF Corporation. He has been presenting this and other short courses at major conferences for the past several years and has served on several professional organization task forces including AAMI, ASQC, ASTM, CMA, and ILAC.

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