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2nd Advanced GMP Workshops 2017
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2nd Advanced GMP Workshops 2017

2nd Advanced GMP Workshops 2017

Chandigarh, Goa, Ahmedabad, Hyderabad November 6, 2017

Flyers

2nd Advanced GMP Workshops 2017- Flyer

2nd Advanced GMP Workshops 2017- Flyer

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Agenda

2nd Advanced GMP Workshops 2017- Agenda 1

2nd Advanced GMP Workshops 2017- Agenda 1

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2nd Advanced GMP Workshops 2017- Agenda 2

2nd Advanced GMP Workshops 2017- Agenda 2

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2nd Advanced GMP Workshops 2017- Agenda 3

2nd Advanced GMP Workshops 2017- Agenda 3

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Speakers

Presentation

Session 1: Quality Systems- Patrick Costello, EMA

Session 1: Quality Systems- Patrick Costello, EMA

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Session 2: Introduction to Data Reliability- Mark Birse/Richard Andrews, MHRA

Session 2: Introduction to Data Reliability- Mark Birse/Richard Andrews, MHRA

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Session 3: Data Quality in Application Submissions- Krishna Ghosh, USFDA

Session 3: Data Quality in Application Submissions- Krishna Ghosh, USFDA

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Session 4: Regulatory Perspective on Data Integrity- Carmelo Rosa, USFDA

Session 4: Regulatory Perspective on Data Integrity- Carmelo Rosa, USFDA

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Session 7: Quality Issues in Aseptic Processes

Session 7: Quality Issues in Aseptic Processes

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

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

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Session 9: Data Quality and Integrity Investigations in Manufacturing and Documentation Practices- Patrick Costello, EMA

Session 9: Data Quality and Integrity Investigations in Manufacturing and Documentation Practices- Patrick Costello, EMA

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Session 10: Laboratory OOS Investigations- Carmelo Rosa, USFDA

Session 10: Laboratory OOS Investigations- Carmelo Rosa, USFDA

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Session 11: Current Trends in Data Quality and Integrity Issues in Inspections and Risk Based Approach to Investigation- Mark Birse/ Richard Andrews, MHRA

Session 11: Current Trends in Data Quality and Integrity Issues in Inspections and Risk Based Approach to Investigation- Mark Birse/ Richard Andrews, MHRA

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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 12: Current Trends in Data Quality and Integrity Issues in Inspections and Risk Based Approach to Investigations: US Perspective- Carmelo Rosa / Quallyna Porte, USFDA

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Session 15: Remediation, Resolution, and Outcomes- Carmelo Rosa, USFDA

Session 15: Remediation, Resolution, and Outcomes- Carmelo Rosa, USFDA

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