Current Good Manufacturing Practices(cGMP) in Pharmaceuticals - February 9, 2019

Time: 2:00pm – 8:30pm Download PDF
Duration: 10 Weeks  
Venue: CEE@IBA,Karachi Reg Form
Info: ceeinfo@iba.edu.pk  
Contact: Tel: (0213) 8104700 (Ext:1804, 1807, 1809)  
  • Introduction

    For years, the Pharmaceutical Manufacturing Industry of Pakistan enjoyed respect and recognition in the region. During the last decade, the scenario has significantly changed mainly because of challenging regulatory requirements and global technological / knowledge driven advancements. IBA/ CEE jointly along with the leaders of Pharmaceutical Industry are providing the launching pad for renaissance.

    Training in current Good Manufacturing Practices (cGMP) is the first step. The courses are designed keeping in view national and international regulatory requirement. The aim is to groom Pharma professionals with skill sets for quality deployment in local industry and to make them understand how important it is to adapt quality measures in cGMP compliant operations and hence enable business to go into international markets.

  • Course Contents
    • Introduction to cGMP and monitoring KPIs
    • Risk Assessment of Product Quality through Supply Chain
    • Regulatory Governance, Serialization & e Submission
    • Documentation and Data Integrity
    • Production Operations
    • Laboratory Controls
    • Validation, Change Management, Deviation Handling & Continuous Improvement
  • Who should attend?
    • Those in Production, QA/QC, Regulatory Affairs, Warehousing, Third party and Engineering.
    • Those on board or aspiring to work in the manufacturing industry.
  • Benefits?
    • A knowledge of "how things work" and how they impact the quality of product
    • An appreciation of the regulated and compliant pharmaceutical environment
    • It helps to advance your career and boosts organization's bottom line through your mastery of quality skills.
  • Faculty
    Dr. Bilquis Yasmeen

    Dr. Bilquis Yasmeen is an experienced facilitator in the areas of Quality Assurance, Operational Excellence/ Lean Sigma & leadership. She did her doctorate from University of Manchester, UK. She is a Lean Sigma Master Black Belt, Certified Quality Auditor, Certified Green Productivity Assessor, Certified Trainer/ Leadership Advocate and Certified cGMP Pharmaceutical Professional. Dr. Yasmeen worked in GSK for sixteen years & has versatile experience of various business roles such as Operations Head, Global Quality Auditor, Lean Sigma Champion, Lean sigma Expert, Lean Sigma Project Assessor, QA Manager, Head of Supply Chain and Leadership Advocate. She rolled out Lean cGMP processes at GSK sites of Pakistan. Conducted training both locally and abroad. Currently she is working with VRI (Variance Reduction International), USA providing Lean Sigma services in consulting, training and mentoring. From the platform of her own company OEC (Operational Excellence Consulting), she is also providing cGMP training/ deployments, Productivity and operational excellence services to Espire/Bfz, SMEDA, JICA and different organizations to enable them to deliver process excellence and hence improving bottom line results and overall growth.

  • Fees
    PKR 45,000/participant:
    • Inclusive of Course material, IBA Workshop Certificate, Lunch, Refreshments & Business networking
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