2017





2nd 2nd Advanced GMP Workshops 2017

India Pharmaceutical Forum 2017 Date: 23 -24 February 2017Location: Mumbai

2nd Advanced GMP Workshops 2017

India Pharmaceutical Forum 2017 Date: 23 -24 February 2017Location: Mumbai

Paula Katz

Director, Manufacturing Quality Guidance and Policy, CDER's Office of Compliance USFDA

View Details

Mathew T Thomas

Director USFDA India Office

View Details

Mary Lou Valdez

Associate Commissioner and Director of the Office of International Programs, USFDA

View Details

K L Sharma

Joint Secretary Ministry of Health & Family Welfare

View Details

Gerald W Heddell

Director, Inspection Enforcement & Standards MHRA

View Details

Gautam Kumra

Managing Director McKinsey & Company

View Details

Florence Benoit-Guyod

Head, Inspection Section EDQM

View Details

Dilip G Shah

Secretary General Indian Pharmaceutical Alliance

View Details

Chandrashekar Ranga

Deputy Drugs Controller (I) CDSCO

View Details

Caroline Larsen Le Tarnec

Head Public Relations & Documentation Division EDQM

View Details

Brendan Cuddy

Head of Manufacturing and Quality Compliance, Compliance & Inspections Department EMA

View Details

Alicia Mozzachio

Senior Advisor,International Activities Office, Policy for Pharmaceutical Quality (OPPQ). USFDA

View Details

Vivek Arora

Partner, McKinsey & Company

View Details

Vikas Bhadoria

Senior Partner, McKinsey & Company

View Details

Umang Vohra

Managing Director & Global Chief Executive Officer, Cipla

View Details

Satish Reddy

Chairman Dr Reddy's Laboratories Ltd.

View Details

Samir Mehta

Chairman Torrent Pharmaceuticals Ltd & Vice Chairman Torrent Group

View Details

Nilesh Deshbandhu Gupta

Managing Director and Executive Director to the Board Lupin Limited

View Details

Mark Birse

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

View Details

Kartik Reddy

Expert Associate Partner, Mckinsey and Company

View Details

Jaidev Rajpal

Partner, McKinsey & Company

View Details

G N Singh

Drugs Controller General of India

View Details

Dilip Shanghvi

Managing Director, Sun Pharmaceutical Industries Limited

View Details

David Keeling

Senior Partner, McKinsey & Co

View Details

Pankaj R Patel

Chairman, Zydus Cadila

View Details

2nd Advanced GMP Workshops 2017

2nd Advanced GMP Workshops 2017

Day 1

Session 1:
Quality Systems

Patrick Costello, EMA

Session 2:Introduction to Data Reliability

Mark Birse/Richard Andrews, MHRA

Session 3:Data Quality in Application Submissions

Krishna Ghosh, USFDA

Session 4:Regulatory Perspective on Data Integrity

Carmelo Rosa, USFDA

Day 2

Session 7:Quality Issues in Aseptic Processes

Thomas Arista, USFDA

Session 8:Data Quality and Integrity Investigations in the Laboratory (Analytical)

Ademola Daramola, USFDA

Session 9:Data Quality and Integrity Investigations in Manufacturing and Documentation Practices

Patrick Costello, EMA

Session 10:Laboratory OOS Investigations

Carmelo Rosa, USFDA

Session 11:Current Trends in Data Quality and Integrity Issues in Inspections and Risk Based Approach to Investigation

Mark Birse/ Richard Andrews, MHRA

Session 12:Current Trends in Data Quality and Integrity Issues in Inspections and Risk Based Approach to Investigations: US Perspective

Carmelo Rosa / Quallyna Porte, USFDA

Session 15:Remediation, Resolution, and Outcomes

Carmelo Rosa, USFDA

India Pharmaceutical Forum 2017 Date: 23 -24 February 2017Location: Mumbai

Session 2 : Reflections on Journey So Far

Vikas Bhadoria, McKinsey & Co

Session 2 :
Release of IPA Data Reliability Guidelines

Session 3 :
EMA’s Guidance on Data Integrity

Brendan Cuddy, EMA

Session 4 :
India’s Regulatory Reforms

V G Somani, CDSCO

Session 4 :
India’s Regulatory Reforms

R Chandrashekar, CDSCO

Session 4 :
India’s Regulatory Reforms

V G Somani, CDSCO

Session 5 :
Building a Strong Quality Culture and Line Ownership

Alicia Mozzachio, USFDA

Session 5 :
Building a Strong Quality Culture and Line Ownership

Gerald Heddell, MHRA

Session 6 :
Batch Failure Investigation

Alicia Mozzachio, USFDA and Mark Birse, MHRARead More

Session 7 :
Complaints – Investigation & Review

Mathew T Thomas, USFDA

Session 8 :
Compliance Trends

Paula Katz, USFDA

Session 8 :
Compliance Trends

Mark Birse, MHRA

Session 9:
How to Benefit from EDQM Inspections

Caroline Le Tarnec, EDQM

Session 9:
Most Common Deficiencies Found by EDQM

Florence Benoit-Guyod, EDQM

Session 10:
Quality Metrics

Paula Katz, USFDA

Session 10:
Quality Metrics

Brendan Cuddy, EMA