1773 Kings Road, Vista, CA 92084-3640, USA
Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com
GMP-Supporting Manufacturing Facilities
- Planning - Design - Validation - Maintenance
Course Content:
GMP Overview
Function of Facilities
General Design Concepts
Segregation
Unidirectional Flow
Multistory Facilities
Site Selection
Materials Handling
Storage Facility Design
Chemically Synthesized APIs
Process Examples
Explosion-proof Design
Facility Design
Biopharmaceutical APIs
Cell Culture / Fermentation
Product Recovery
Product Purification
Bulk Fill
Biologics
Blood Products
Cell Products
Gene Therapy Products
Vaccines
Final Dosage
Fill and Finish
Orally administered Products
Parenteral Products
Contaminant Control
Process Segregation
Cleaning, Sterilization and Sanitation
Controlled Environments
Cleanroom Classes
Cleanroom Design
HVAC Design
Waste Handling
Utility Systems
Electrical Power
Water
City / Well
Purified
WFI
Steam
Process
Clean
Process Gases
Vacuum
Waste Handling
Design for Best Economy
Architectural Finishes
Minimization of Cleanroom Space
Clean-Built Construction
Pilot Plants vs. Manufacturing Facilities
Dedicated vs. Multiproduct Facilities
Facility Validation
Design Qualification
Construction Qualification
Operational Qualification
Performance Qualification
Facility Maintenance
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