Short Course Listings
 
Short Course

Course Information
Course Title: Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ)
Categories: 1 - Liquid Chromatography
2 - Liquid Chromatography-Mass Spectrometry
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
6 - Laboratory Information and Management
Instructor(s): Shib Mookherjea Course Number: 68
Affiliation: ValQual International, Inc.
Course Date: 03/09/2017 - Thursday 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
Course gives conceptual background of Qualification & Validation of instruments, apparatus, etc. from risk assessment & product lifecycle perspective w/examples, specifications, protocols & SOP requirements & use of equipment, instruments. Requirements testing & acceptance criteria to calibrate, standardize or validate laboratory equipment/process equipment etc. (e.g. HPLC, GC, MS, Dissolution apparatus/blenders, etc. or common Instruments, meters & devices in plant, micro labs, aseptic areas & processing departments throughout functions in the cGMP facilities. Examples discussed w/acceptance criteria, w/lab systems & QC/QA perspectives. Regulatory aspects & global guidelines discussed (ICH Q9, ASTM, ISO).

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
• Introduction/Quality Systems
• Regulatory Requirements and FDA Directives
• ICH Q7,Q2(R1) and other Guidelines
• Measurement Resolution and Errors
• Calibration Standardization and Validation
• Product Lifecycle Concept
• Responsibilities of Vendors and Users
• IQ/OQ/PQ and PM
• Validation and Qualification Strategies; Risk Assessment Approach
• ICH Q9
• Documentation Strategies; Master Validation Plan and Protocols
• Examples of OQ and PQ
• Qualification of Systems for Imaging & Surface Properties (SEM, Micro CT, Confocal Raman, etc.)
• HPLC Systems
• Dissolution Apparatus
• TOC, LC-MS and others
• PQ vs. System Suitability
• Training Requirements
• Recent Harmonization Efforts
• References and Conclusions

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 (www.valqualintl.com). He provides global training and consulting in areas of Validation, Methods & Audits for GMP, GLP (FDA/OECD), and ISO 17025.