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