FDA has announced major reorganization which will affect GMP inspections
Plans for major reorganization has been announced by FDA which will become effective on January 2015.New office of Pharmaceutical Quality will be introduced in the center of reorganization.According to an email sent to CDER employees on 16th October 2014 Woodcock would serve as the first acting director of OPQ with support from Deputy Director Lawrence Yu, who replaced Webber as acting director of OPS in September 2013.Others joining OPQ would be
1 Office of Programme and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
2 Office of Policy for Pharmaceutical Quality (OPRQ): Ashley Boam (Acting)
3 Office of Biotechnology Products (OBP): Steve Kozlowski (Director)
4 Office Of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
5 Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
6 Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
7 Office of Process and Facilities (OPF): Christine Moore (Acting)
8 Office of Surveillance (OS): Theresa Mullin (Acting)
The reorganization will have major impact on all the inspections carried out by FDA in terms of its efficiency improvement of enforcement studies.