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The successful design and realization of an FDA-validatable facility does not happen by chance. Early coordination and communication among all parties involved is essential, from process design and scale-up through cGMP layout, FDA pre-construction design review, commissioning, validation, and on-site inspection by regulatory authorities. A complete "Basis of Design" document is necessary to optimize the utilization of scarce resources. Time spent in design optimization in the front-end, well in advance of the "bricks and mortar" stage, will be saved many times over.

  • Date: 21/03/2018 10:00 AM
  • Location HolidayInn , city stars , Egypt (Map)


A. Project Description
B. Master Planning
C. Local regulatory constrains
D. Capacity analysis
E. Hygiene zones
a) Classification concept
b) Changing procedures
c) HVAC Schematics
F. Personnel & material flow
G. Conceptual layouts
H. Logistics
I. Rooms data sheets
J. Equipment List
K. Time Schedule
L. Cost Estimate

3 days
8 - 15