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 - Laboratory Information and Management
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Shib Mookherjea Course Number: 41
Affiliation: ValQual International, Inc.
Course Date: 03/10/2016 - Thursday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $550 ($750 after 2/12/16) Textbook Fee:

Course Description
The course gives a conceptual background of Qualification & Validation of various Laboratory Systems, instruments, gadgets, meters etc. from a Risk based assessment and also the lifecycle perspectives, with examples, specifications, protocols & SOP requirements as needed. The 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), will be used. Examples will be discussed for acceptance criteria, with lab systems & QC/QA perspectives. The Regulatory aspects and the scenario global guidelines will also be discussed (ICH Q9, USP ASTM, ISO, ISPE ,PDA …).

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, PhD, has a proven track record in analytical problem solving, with extensive accomplishments in the areas of Analytical R&D Management, Pharmaceutical Development, (ICH), Management of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in Methods, Systems, Equipment Qualification. He has guided internal Analytical, Process Development and Quality Teams in various settings. He has held management and supervisory positions within Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF, CRO/CMO Laboratories, Ethicon/Ortho Pharmaceutical and Allergan Medical. Dr. Mookherjea is a highly recognized speaker and has conducted numerous workshops, short courses and seminars in various conferences, expositions and trade shows, in more than 20 countries. He 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, TQM, ISO 9000, Laboratory QA, and Accreditation. He is part of the continuing education faculty of the American Chemical Society, EAS, CFPA and other international training organizations. Dr. Mookherjea has overcome many challenges, which have been successfully met in various corporate settings, by providing the needed training and guidance, utilizing a worldwide network of scientific professionals. He remains an excellent source of reference and assistance in problem solving. Connect with him on LinkedIn at https://www.linkedin.com/pub/shib-mookherjea/25/54a/223