What You Will Learn
Learn the elements of Quality Assurance principles and techniques,
the benefits they provide, and how to implement them in your
organization and your work. Gain an understanding of the
requirements for regulatory submissions and laboratory
accreditation. Understand the steps necessary to develop an
effective Quality Management program and put it into operation.
Who Should Attend
Laboratory professionals, scientists, administrators; QA and QC
professionals and managers; purchasing managers; R&D managers,
anyone needing a comprehensive introduction to
Quality Assurance and guidance in how to implement it.
Topics
| • | Quality Awareness |
| • | Quality Management Systems |
| • | Impact of Quality Management on the Laboratory |
| • | Elements of Quality Systems |
| • | Protocol and Documentation |
| • | Standard Operating Procedures |
| • | Methodology |
| • | Work Instructions |
| • | Development of Quality Systems for the Laboratory |
| • | Preparation of the Quality Manual |
| • | GLP Requirements of Methods Validation |
| • | Personnel |
| • | Sample Management |
| • | Environmental Concerns |
| • | Laboratory Accreditation |
| • | Applications of ISO Guide 25 |
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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