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
Bulletproof
Validation
of Methods, Equipment, Process, Utilities and Facility
A 3-Day Intensive Continuing Education Course 1.8 CEU's)
Course Faculty: Frieder
K. Hofmann, Ph.D.
Course Content:
The Why, Who, How, Where and When of Validation
Validation Approach
Content and Format of the Master Validation Plan
Phases of Validation
Design Qualification
Analytical Methods Validation
Installation Qualification
Operation Qualification
Software Qualification
Cleaning Validation
Performance Qualification
Computer Validation
Process Validation
Revalidation
Documentation
Validation Protocol and Records
Facility Validation
Location
Manufacturing Process
Layout
Cleanliness Requirements
Utilities
Water Systems
Steam Systems
Compressed Gases
Electricity
Multi-product Facilities
Concurrent Facility Validation
Process Equipment Validation
Reactors
Ultrafilters
Sterile Filters
Autoclaves
Purification Equipment
Aseptic Filling Line
Lyophilizer
Process Validation
Production History
Validation Runs
Robustness Verification
Validation Contractors
Selection Criteria
Supervision
Copyright Center for Continuous Education