2019
4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019
Session :
CGMPs Aspects of NCE Development for Early Phase INDs – CMC Perspective
Balaram Rao, Aurigene
Session :
Leveraging Automation in Pharmaceutical Operations for Continuous Improvement
Ganadhish Kamat, Dr Reddy’s
Session :
Recent Trends in Inspection of Sterile Dosage Form
Philip E M Crooker, USFDA
Session :
Experience of Transformation of Culture with respect to Quality – Experience Sharing by Companies
Sunil Kumar, Cipla
Session :
Data Integrity: New PDA Technical Reports on DI in the Laboratory, Manufacturing, and QMS Systems
Tina Morris, PDA
Session :
Experience of Transformation of Culture with respect to Quality – Experience Sharing by Companies
Vikram Shukla, Pfizer
4th India Pharmaceutical Forum 2019 Date: 27 – 28 February 2019Location: Mumbai
Day 1
Session 1:
Opening Remarks
Investigations for Non-Conformities Guideline: Focus on Batch Failure Investigations
Session 3:
Concept of Operations and How it May Impact Inspections, Review and Approval
Dr Yuexia Li, PAREXEL Consulting
Session 4:
How to Build and Maintain an Effective Pharmaceutical Quality Management System
Dr Ajaz Hussain, NIPTE
Day 2
Session 6:
Implications of Brexit for Pharamceutical Industry
Mr David Churchward, MHRA
Session 6:
Regulatory Update on GMP, Safety Features Regulation and Brexit
Ms Maria Filancia, EMA
Session 8:
Creating Platform for Entry Level Training for Quality Culture: Challenges and Outcomes
Mr Rahul Guha, Boston Consulting Group, India
Session 8:
Best Practices, Metrics and Symbolic Actions
Mr Vivek Arora, McKinsey & Co
Session 9:
Disruptive Technologies in Pharma Operations
Mr Parag Patel, McKinsey & Co
Session :
Experience of Transformation of Culture with respect to Quality – Experience Sharing by Companies
Vikram Shukla, Pfizer
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