2018





3rd Advanced GMP Workshops 2018 Date: 12 – 20 November 2018

India Pharmaceutical Forum 2018 Date: 22 -23 February 2018Location: Mumbai

3rd Advanced GMP Workshops 2018 Date: 12 – 20 November 2018

India Pharmaceutical Forum 2018 Date: 22 -23 February 2018Location: Mumbai

Vivek Arora

Partner, McKinsey & Company

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Umang Vohra

Managing Director & Global Chief Executive Officer, Cipla

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Satish Reddy

Chairman Dr Reddy's Laboratories Ltd.

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Samir Mehta

Chairman Torrent Pharmaceuticals Ltd & Vice Chairman Torrent Group

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Sharvil Patel

Managing Director, Cadila Healthcare Ltd

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R K Vats

Additional Secretary, Ministry of Health and Family Welfare

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Nilesh Deshbandhu Gupta

Managing Director and Executive Director to the Board Lupin Limited

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Mark Birse

Head of Inspectorate , Medicines and Healthcare products Regulatory Agency (MHRA)

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Kartik Reddy

Expert Associate Partner, Mckinsey and Company

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Jaidev Rajpal

Partner, McKinsey & Company

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Howard Sklamberg

Partner, Akin Gump Strauss Hauer & Feld LLP

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Glenn Saldanha

Chairman & Managing Director, Glenmark Pharmaceutical Ltd

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Gerald Heddell

Director of Inspection, Enforcement & Standards, Medicines...

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G N Singh

Drugs Controller General of India

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Dilip Shah

Secretary General, Indian Pharmaceutical Alliance

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David Keeling

Senior Partner, McKinsey & Co

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Bart Janssens

Senior Partner and Director, The Boston Consulting Group, India

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Andrei Spinei

Scientific Administrator, EMA

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Ademola Daramola

Assistant Country Director, International Relations Specialist (Drugs)...

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Dilip Shanghvi

Managing Director, Sun Pharmaceutical Industries Limited

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Vikas Bhadoria

Senior Partner, McKinsey & Company

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3rd Advanced GMP Workshops 2018Date: 12 – 20 November 2018

India Pharmaceutical Forum 2018Date: 22 -23 February 2018Location: Mumbai

3rd Advanced GMP Workshops 2018 Date: 12 – 20 November 2018

Day 1

Session 1:
Setting the Context

Letitia Robinson, USFDA

Session 1: Setting the Context

Vimal Sachdeva, WHO

Session 1: Setting the Context

Ewan Norton, MHRA

Session 2:Key Trends in Quality and GMP Inspections

Thomas Arista

Session 3:Quality Metrics with Case Study

Ranjana Pathak

Session 3:Quality Metrics with Case Study

Jaidev Rajpal/Vivek Arora

Session 4:Good Data and Record Management Practices – Sharing of Experiences & Issues

Vimal Sachdeva

Session 5:Organization Culture – Expectations of a Regulator

Ewan Norton

Day 2

Session 7:FDA Inspection Process – What You Should Anticipate

Robert Iser

Session 8:Building Quality Culture and Capabilities

Jiwan Goyal

Session 8:Building Quality Culture and Capabilities

Jaidev Rajpal/Vivek Arora

India Pharmaceutical Forum 2018 Date: 22 -23 February 2018Location: Mumbai

Day 1

A. Batch Failure Investigation
Session 1 : Setting the Context

Mr Vivek Arora, McKinsey & Co

Session 2, 3 & 4 :
Data Quality and Integrity 1, 2 & 3

Mr Howard Sklamberg, Akin and Gump

B. Complaints-Investigation and Review
Session 1 :
Setting the Context

Dr Jaidev Rajpal, McKinsey & Co

Session 2 :
How to Proceed – Essential Parameters

Dr Ademola Daramola, USFDA

Session 3 :
Root Cause analysis

Dr Ademola Daramola, USFDA

Session 4 :
Remediation, Resolution and Outcomes

Mr Andrei Spinei, EMA

C. Good Documentation Practice
Session 1 :
Setting the Context

Mr Kartik Reddy, Mckinsey & Co.

Session 2 :
Practical Steps to Good Documentation

Mr Gerald Heddell/Mr Mark Birse, MHRA

Session 3 & 4:
How to Ensure Good Documentation Practice – Consequences of Poor Documentation

Mr Gerald Heddell/Mr Mark Birse, MHRA

Day 2

Session 2:
Reflections on Journey So Far

Mr Vikas Bhadoria, McKinsey & Co

Session 2:
Reflections on Journey So Far

Dr Jaidev Rajpal, McKinsey & Co

Session 2:
Reflections on Journey So Far

Mr Vivek Arora, McKinsey & Co

Session 2:
Reflections on Journey So Far

Process Validation Guideline

Session 2:
Reflections on Journey So Far

Good Documentation Practice Guideline

Session 3:
Driving Sustainable Cultural Transformation

Mr Andrei Apinei – EMA

Session 3:
Driving Sustainable Cultural Transformation

Mr Gerlad Heddell, MHRA

Session 4:
Building Integrated Capabilities for Quality Excellence

Mr Bart Janssens, Boston Consulting Group

Session 4:
Building Integrated Capabilities for Quality Excellence

Mr David Keeling, McKinsey & Co

Session 5:
Building Quality Metrics

Mr Howard Sklamberg, Akin Gump

Session 5:
Building Quality Metrics

Mr Mark Birse, MHRA

Session 5:
Building Quality Metrics

Dr Ademola Daramola, USFDA

Session 6:
Electronic Documentation

Mr Mark Birse, MHRA