2019




4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019

4th India Pharmaceutical Forum 2019 Date: 27 – 28 February 2019Location: Mumbai

4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019

4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019

4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019

4th Advanced GMP Workshops 2019 Date: 11 – 19 November 2019

Session :
Recent Trends in Inspection of Sterile Dosage Form

Alonza Cruze, USFDA

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 :
Continuous Manufacturing – Current Trends

Harish Krishnan, GEA

Session :
QBD in Analytical Development

Jila Breeze, Sun

Session :
Recent Trends in Inspection of Sterile Dosage Form

Philip E M Crooker, USFDA

Session :
Robust Technology Transfer

Roberto Concchia, EMA

Session :
Validation of Analytical Methods

Sharad Mankumare, USP India

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 :
Excipients Risk Management: New PDA Technical Report

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

Dr Letitia Robinson, USFDA

Session 1:
Opening Remarks

Ms Maria Filancia, EMA

Session 1:
Opening Remarks

Investigations for Non-Conformities Guideline: Focus on Batch Failure Investigations

Session 2:
Reflections on Journey So Far

Mr Vikas Bhadoria, McKinsey & Co

Session 2:
Building Quality Culture and Capabilities

Dr Jaidev Rajpal, McKinsey & Co

Session 2:
Experience of Dr Reddy’s

Mr Jiwan Goyal, Dr Reddy’s

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

Session 5:
Driving Sustainable Cultural transformation

Mr David Churchward, MHRA

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 7:
The Valsartan Incident and Lessons Learnt

Ms Hélène Bruguera, EDQM

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 8:
Experience of Sun Pharmaceutical

Ms Jila Breeze, Sun Pharmaceutical

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