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GMPs IN THE 21st CENTURY

CHAIR:
Prof. Michael Anisfeld (USA)
CO-CHAIR:
Dr. Linda Hakes (GERMANY)

February 7, 2012

7:30—8:30 Registration/Sign-In
8:30—9:30 Global GMPs - Where the World is Headed for 2020
Prof. Michael Anisfeld (USA)
9:30—10:30 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.)
Prof. Michael Anisfeld
10:30—11:00 Coffee Break
11:00—1:00 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.) - Cont’d
Prof. Michael Anisfeld
1:00—2:00 Lunch
2:00—3:30 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.) - Cont’d
Prof. Michael Anisfeld
3:30—4:00 Coffee Break
4:00—5:00 Risk Management Case Studies
Dr. Linda Hakes (GERMANY) 13

February 8, 2012

7:30—8:30 Registration/Sign-In
8:30—9:30 Global GMPs - Where the World is Headed for 2020
Prof. Michael Anisfeld (USA)
9:30—10:30 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.)
Prof. Michael Anisfeld
10:30—11:00 Coffee Break
11:00—1:00 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.) - Cont’d
Prof. Michael Anisfeld
1:00—2:00 Lunch
2:00—3:30 Risk Management and Effective Investigations of
Quality Incidents (OOS, OOT, Deviations, etc.) - Cont’d
Prof. Michael Anisfeld
3:30—4:00 Coffee Break
4:00—5:00 Risk Management Case Studies
Dr. Linda Hakes (GERMANY)
8:30—9:30 GMPs for Development Laboratories
Dr. Linda Hakes
9:30—10:30 Development Labs Case Studies
Dr. Linda Hakes
10:30—11:00 Coffee Break
11:00—1:00 Managing the QC Lab in a GMP Compliant Manner
Prof. Michael Anisfeld
1:00—2:00 Lunch
2:00—3:30 Managing the QC Lab in a GMP Compliant Manner - Cont’d
Prof. Michael Anisfeld
3:30—4:00 Coffee Break
4:00—5:00 QC Lab Case Study Dr. Linda Hakes

February 9, 2012

8:30—10:30 Essentials of Validation
Prof. Michael Anisfeld
10:30—11:00 Coffee Break
11:00—1:00 Essentials of Validation - Cont’d
Prof. Michael Anisfeld
1:00—2:00 Lunch
2:00—3:30 Validation Case Studies
Dr. Linda Hakes
3:30—4:00 Coffee Break
4:00—5:00 Summary and Discussions