What You Will Learn
Become familiar with the different ISO 9000 standards and their relevance to the pharmaceutical and chemical industries. Learn how to prepare your organization for the ISO 9000 audit process. Learn the basics of Total Quality Management (TQM) and what tools and strategies are important for the implementation of TQM.
Who Should Attend
Laboratory professionals, scientists, administrators; QA and QC professionals and managers; purchasing managers; R&D managers, anyone needing a comprehensive introduction to ISO 9000 and TQM as it relates to the chemical and pharmaceutical industries.
|||Comparison of the different ISO 9000 series standards|
|||Common elements of TQM and ISO 9000|
|||Expansion of the elements relevant to the chemical and pharmaceutical industries|
|||Regulatory requirements (GLP, GMP) and international standards|
|||Inter-relationships of international committees and organizations|
|||The audit process and selection of registrars|
|||Preparing for ISO 9000 Certification|
|||Total Quality Management systems and organizational change|
|||Special considerations and documentation for R&D organizations|
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.