Short Course - Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ)

Course Information

Course Title:	Qualification and Validation of Laboratory Instruments and Equipment for Regulatory and QS Compliance (IQ, OQ, PQ)
Categories:	1 - Pharmaceutical Sciences 2 - Quality/Regulatory/Compliance 3 - Regulatory Compliance 4 - Validation 5 - Laboratory Information and Management
Instructor(s):	Shib Mookherjea	Course Number:	42
Affiliation:	ValQual International Inc
Course Date:	03/03/2010	Course Length:	1 Day Course
Start Time:	08:30 AM	End Time:	05:00 PM
Fee:	$425 ($625 after 2/1/10)	Textbook Fee:

Course Description

This course gives a conceptual background of the qualification and validation of various instruments, apparatus, devices, systems and equipment from a risk assessment and product lifecycle perspective with several examples, specifications, protocols and SOP requirements at various stages of deployment and use of various equipment, instruments, etc. It scopes out the requirements testing and acceptance criteria to calibrate, standardize or validate as appropriate various laboratory equipment/plant/process equipment/devices/gadgets/recorders/on line monitors/meters/micro devices (e.g. HPLC, GC, MS, Dissolution Apparatus/blenders/mixers/stability chambers/auto-claves or common Instruments, meters and devices in plant, production micro labs, aseptic areas and processing departments throughout various functions in the cGMP facilities. Examples are discussed with acceptance criteria, particularly with lab systems and their QC/QA perspectives. The regulatory aspects and global guidelines will be discussed with documentation strategies, including PVP, validation protocols, SOP’s, charts, forms, data sheets, etc., with global guidelines discussions from a risk assessment (ICH Q9, ASTM, ISO) approach.

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
• 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.