Short Course Listings
Short Course

Course Information
Course Title: Designing and Maintaining a Robust Quality System for Regulated (Food, Pharma, Biotech…) Laboratories
Categories: 1 - Clinical Analysis
2 - Pharmaceutical Sciences
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
6 - Laboratory Information and Management
Instructor(s): Shib Mookherjea Course Number: 67
Affiliation: ValQual International, Inc.
Course Date: 03/08/2017 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
In the highly regulated industries, various Quality Measures, Quality Planning and Quality Management, including Quality Control (QC), Quality Assurance (QA) are required in order to meet the requirements from various Regulatory Agencies and International Organizations (FDA, EMEA, ICH, WHO, etc.). An encompassing Quality System often needs to be in place for the management to have oversight and monitoring of various such measures and activities. This short 1 Day presentation will aim at identifying the attributes and characteristics of a robust Quality System while enumerating the steps needed to design and maintain such Quality Systems. Some of the basic tenets of standards like ISO 9001:2015 and other international guidelines will be discussed vis-a vis the requirements of c GMP, GLP, ISO 17025 as relevant for various laboratories.

Target Audience
Scientists/Managers R&D Personnel QA/QC Staff Validation Coordinators Quality Assurance Managers Production and Packaging Personnel Regulatory/Compliance Managers Warehouse Managers, Distribution Chain Qualified Persons (EMEA) Distributor, Pharmaceutical, Supply, & Purchasing Managers, Shippers

Course Outline
Quality, the Quality Continuum
The Global scenario and Harmonization
Emergence of various Quality Standards and Guidelines
FDA’s 21st Century GMP’s
The Quality Systems approach
The Quality Manual
Documentation, Systems, Procedures , SOP’s
Quality Function Deployment
Quality Control (QC), Quality Assurance (QA)
Various attributes and characteristics
Examples and Class Exercise
Questions & Answers

Course Instructor's Biography
Shib Mookherjea has a proven track record in analytical problem solving, R&D and extensive accomplishments in the areas of Pharmaceutical Development, (ICH Q6, Q7A, Q8), Management of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in the laboratory (Methods, Systems, Equipment Qualification), and support for dosage forms, in process materials, excipients, DS, DP, medical devices, etc. He has held Management and supervisory positions within Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF & CRO/CMO Laboratories. Dr. Mookherjea is a highly-recognized speaker and is the Principal of VQI ( He provides global training and consulting in areas of Validation, Methods & Audits for GMP, GLP (FDA/OECD), and ISO 17025.