Course Information
Course Title: Highlights of FDA GLP
Categories: 1 - Clinical Analysis
2 - Data Management
3 - Laboratory Information and Management
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Shib Mookherjea Course Number: 17
Affiliation: ValQual Intl.
Course Date: 03/14/2012 - Wednesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $455 ($655 after 2/13/12) Textbook Fee:

Course Description
This course will cover some of the major requirements, definitions and elements of various GLP regulations and the FDA/OECD GLP’s. It scopes out the roles & responsibilities of the Study Director, Management & QAU function in GLP testing facilities. Comparison & differences between the FDA & OECD GLP’s will be included. Presentation aims at bringing out basic tenets & elements of GLP’s from the directives & regulations. The basic process of conduct of GLP studies including the development of GLP study protocols, final reports, archiving requirements of In Phase Audits, & other details will be included. Case histories, real-life applications, & group exercises are an integral part of this intensive presentation.

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

Course Outline
•        Introduction: FDA’s Recent Directives
•        The GLP Organization: Management, Sponsors, Study Directors and Other Roles
•        Facilities
•        Equipment: Instruments, Gadgets
•        Reagents & Solutions
•        Test Articles
•        Test System
•        Protocols: Development/Execution
•        SOPs and Documentation
•        GLP Study Conduct
•        GLP Final Report
•        Archiving
•        Quality Assurance Unit
•        Subcontracting CROs
•        Regulatory Aspects/Disqualifications
•        Validation & Qualification Issues:
•        CFR 21 Part 11
•        Methods Validation
•        Equipment Qualification - IQ/OQ/PQ
•        References & Acknowledgments
•        Conclusion

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.