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Events

Past Events 2017

2nd Advanced GMP Workshops 2017

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Registration Form

Agenda

Presentations

Day 1

Session 1: Quality Systems

Session 2: Introduction to Data Reliability

Session 3: Data Quality in Application Submissions

Session 4: Regulatory Perspective on Data Integrity

Day 2

Session 7: Quality Issues in Aseptic Processes

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

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

Session 10: Laboratory OOS Investigations

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

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

Session 15: Remediation, Resolution, and Outcomes

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

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Agenda

Speakers

Presentations

Session 2: Reflections on Journey So Far

Session 2 : Release of IPA Data Reliability Guidelines

Session 3: EMA's Guidance on Data Integrity

Session 4: India's Regulatory Reforms

Session 5: Building a Strong Quality Culture and Line Ownership

Session 6: Batch Failure Investigation

Session 7: Complaints - Investigation & Review

Session 8: Compliance Trends

Session 9: How to Benefit from EDQM Inspections

Session 9: Most Common Deficiencies Found by EDQM

Session 10: Quality Metrics