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India Pharmaceutical Forum 2018

Mumbai February 22, 2018

Flyers

India Pharmaceutical Forum 2018- Flyer

India Pharmaceutical Forum 2018- Flyer

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Agenda

India Pharmaceutical Forum 2018- 22 -23 February 2018- Agenda

India Pharmaceutical Forum 2018- 22 -23 February 2018- Agenda

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Speakers

Presentation

A. Batch Failure Investigation Session 1 : Setting the Context- Mr Vivek Arora, McKinsey & Co

A. Batch Failure Investigation Session 1 : Setting the Context- Mr Vivek Arora, McKinsey & Co

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Session 2, 3 & 4 : Data Quality and Integrity 1, 2 & 3- Mr Howard Sklamberg, Akin and Gump

Session 2, 3 & 4 : Data Quality and Integrity 1, 2 & 3- Mr Howard Sklamberg, Akin and Gump

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B. Complaints-Investigation and Review Session 1 : Setting the Context- Dr Jaidev Rajpal, McKinsey & Co

B. Complaints-Investigation and Review Session 1 : Setting the Context- Dr Jaidev Rajpal, McKinsey & Co

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Session 2 : How to Proceed - Essential Parameters- Dr Ademola Daramola, USFDA

Session 2 : How to Proceed - Essential Parameters- Dr Ademola Daramola, USFDA

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Session 3 : Root Cause analysis- Dr Ademola Daramola, USFDA

Session 3 : Root Cause analysis- Dr Ademola Daramola, USFDA

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Session 4 : Remediation, Resolution and Outcomes- Mr Andrei Spinei, EMA

Session 4 : Remediation, Resolution and Outcomes- Mr Andrei Spinei, EMA

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Session 2 : Practical Steps to Good Documentation

Session 2 : Practical Steps to Good Documentation

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

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Session 2: Reflections on Journey So Far- Mr Vikas Bhadoria, McKinsey & Co

Session 2: Reflections on Journey So Far- Mr Vikas Bhadoria, McKinsey & Co

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Session 2: Reflections on Journey So Far- Dr Jaidev Rajpal, McKinsey & Co

Session 2: Reflections on Journey So Far- Dr Jaidev Rajpal, McKinsey & Co

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Session 2: Reflections on Journey So Far- Mr Vivek Arora, McKinsey & Co

Session 2: Reflections on Journey So Far- Mr Vivek Arora, McKinsey & Co

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Session 2: Reflections on Journey So Far- Process Validation Guideline

Session 2: Reflections on Journey So Far- Process Validation Guideline

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Session 2: Reflections on Journey So Far- Good Documentation Practice Guideline

Session 2: Reflections on Journey So Far- Good Documentation Practice Guideline

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Session 4: Building Integrated Capabilities for Quality Excellence- Mr Bart Janssens, Boston Consulting Group

Session 4: Building Integrated Capabilities for Quality Excellence- Mr Bart Janssens, Boston Consulting Group

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Session 3: Driving Sustainable Cultural Transformation- Mr Andrei Apinei - EMA

Session 3: Driving Sustainable Cultural Transformation- Mr Andrei Apinei - EMA

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Session 5: Building Quality Metrics- Mr Howard Sklamberg, Akin Gump

Session 5: Building Quality Metrics- Mr Howard Sklamberg, Akin Gump

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Session 4: Building Integrated Capabilities for Quality Excellence- Mr David Keeling, McKinsey & Co

Session 4: Building Integrated Capabilities for Quality Excellence- Mr David Keeling, McKinsey & Co

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Session 5: Building Quality Metrics- Mr Howard Sklamberg, Akin Gump

Session 5: Building Quality Metrics- Mr Howard Sklamberg, Akin Gump

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Session 5: Building Quality Metrics- Mr Mark Birse, MHRA

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