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.
Topics
| • | Requirements of regulatory submissions |
| • | Good Laboratory Practices (GLP) |
| • | Good Manufacturing Practices (GMP) |
| • | ISO-9000 |
| • | Laboratory accreditation |
| • | Methods development and optimization |
| • | Quality |
| • | Quality Control and Quality Assurance |
| • | Analytic Data Integrity |
| • | Statistical Treatment of Analytical Data |
| • | Validation procedures |
| • | Documentation for regulatory conformance |
Instructor
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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