Events

2nd Advanced GMP Workshops 2017

2nd Advanced GMP Workshops 2017- Flyer

2nd Advanced GMP Workshops 2017- Agenda 1

2nd Advanced GMP Workshops 2017- Agenda 2

2nd Advanced GMP Workshops 2017- Agenda 3

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

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- 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

06 November 2017 - 17 November 2017
Chandigarh, Goa, Ahmedabad, Hyderabad