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Jaydeep D. Chhatrapati

Associate

About Jaydeep D. Chhatrapati


Jaydeep has overall 16 years of experience in the GxP IT systems in the pharmaceutical industry in total 25 years of professional career. He works with QualiCulture Consulting Group on joint assignment basis to provide expertise in computerized systems compliance, related to pharmaceuticals and associated regulatory industry. He serves as as a Subject Matter Expert for defining and implementing Computer System Compliance strategies. He focused on various Computerized System Validation and US FDA 21 CFR part 11, EU GMP Annex 11 and ISPE GAMP 5 Compliance Projects including Process Control Systems (PLC / DCS / SCADA / BMS), Laboratory Computerized Systems, CDS, DMS, QMS, ERP Systems and Clinical Trial Applications like SAS/WinNolin during his entire professional tenure. As part of his responsibilities he has worked for CSV projects in API and finished dosage manufacturing, utilities and quality control functions for implementing regulatory compliant solutions for computerized systems. 
EXPERTISE:       

  • Serve as an SME for Computerized Systems in GxP domain
  • Lead of the compliance matters for IT enablement projects right from the design, qualification, operation and maintenance (throughout lifecycle)
  • Preparation and review of  Computerized Systems validation master plan
  • Preparation of Review of protocols and reports of  Computerized Systems Validation for all types: Control System validation ( DCS / PLC / SCADA / MMI / BMS);  Laboratory Computerized System Software Validation (EMPOWER / Chromeleon/ OpenLab/ SAS / WINNONLINE / HPLC / GC / FTIR / Stability Chambers / LCMS / UV etc; Global Information System Software Validation (ERP / MRP systems like SAP ECC 7.0, J D EDWARDS / ORACLE / RDBMS based systems/DYNAMICS)
  • Review of Inventory Check-list, GAMP Classification and Vendor Documentation
  • Perfroms GxP complaince risk assessment and recommend remedial plan for compliance assurance
  • Identify the Gap in the System Configuration vis—vis Regulatory Guidelines 
  • Recommend / Monitor various challenge tests for system adequacy and compliance
  • Assessments to determine compliance to US FDA 21 CFR Part 11/EU Annex 11 for Electronic Records and Signatures     
  • Review Clients Process and identify the GxP critical areas
  • Review computer System Set Up and architecture 
  • Review Paper vs. Electronic Records
  • Review of data management, backup, archival and retrieval practices and procedures

EXPERIENCE:        

  • Director of  Ingenico Technologies Pvt. Ltd. 
  • Served as an independent consultant for establishing the GxP compliant lifecycle management  processes for more than 30 major Pharmaceutical companies in India and  abroad at UK, Germany, Canada, Egypt, South Africa, Bangladesh, Saudi Arabia, Abu Dhabi etc.

EDUCATION:        

  • Graduate Engineer with specialization in Instrumentation & Control Engineering 

PROFFESSIONAL AFFILIATIONS:        

  • Active member of ISPE since 2001
  • Infrastructure committee member of LSIT-IT for Life Science


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