Workshops
GMPs for the 21st Century
CHAIR: Prof. Michael Anisfeld (USA)
CO-CHAIR: Dr. Linda Hakes (GERMANY)
Workshop Agenda
February 7th 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) |
February 8th 2012
| 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 9th 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 |
Chairs and Speakers
Prof. Michael H. Anisfeld is a senior consultant for Globepharm Consulting specializing in GMP/Quality Assurance and Regulatory activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies (WHO, UNFPA, UNICEF, UNIDO), national regulatory agencies (including the Chinese SFDA, US-FDA, Australian TGA) and over 260 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in the Americas, Africa, Europe and Asia. Professor Anisfeld is a member of the faculty at the College of Pharmacy, University of Illinois, Chicago.
Dr. Linda Hakes has more than 30 years experience in the pharmaceutical industry, and is currently Vice President & Global Project Leader at UCB. Her experience covers pharmaceutical development, preclinical development, clinical trial supplies and quality assurance. Linda is President of the Industrial Pharmacy Section of FIP, former chairman of the Industrial Pharmacists’ Group in Great Britain, visiting professor at the University of Sunderland, and is a Fellow of the Royal Pharmaceutical Society of Great Britain.