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

Course Content:

Planning for Quality
Company Organization
Development of Specifications for
   - Product
   - Materials and Components
   - Unit processes
   - Utilities
   - Equipment
   - Cleanliness
   - Facility

Design Qualification of
   - Product (Design Control)
   - Unit processes
   - Utilities
   - Equipment
   - Facility

Manufacturing Controls
   - Batch Record and supporting SOP’s
   - Calibration Program
   - Materials Testing
   - In-process Testing
   - Utility Testing
   - Environmental Testing
   - Final Product Testing
   - Trending of Test Results

Materials Management
   - Purchasing Control
   - Materials Storage
   - Materials Release
   - Materials Transport
   - Product Storage
   - Product Shipping

Documentation System
Verification of Comprehensive Documentation
The Document Hierarchy
   - Commitment Documents
     - Quality Policies, Master Validation Plan
   - Directive Documents
     - MS, SOP's, MBR, MDR, Validation Protocols
   - Data Collection Documents
     - BR, DHR, Logbooks, Validation Records, Inventory Cards
- Summary Reports

     -Validation Summary Reports, Trend Reports
Document Control
Electronic Documentation

Validation and Qualification
    Test Method Validation
    Materials and Vendor Qualification
    Facility Validation
    Utility Validation
    Equipment, Software and Cleaning Validation
    Operator Training and Qualification
    Process Validation
    Documentation of Validation

Change Management
    Change Prevention
        - Calibration, Preventive Maintenance and Revalidation
        - Auditing and Training
Controlled Change
        - Criticality of Change
         - Off-line Validation
          - Acceptance Decision and Implementation
    Learning from Problems
        - Out-of-Specification Result Handling
        - Customer Complaints
        - Deviations and Non-conformances
        - Root-cause Investigations
        - Decision Power
        - Implementation of Corrective and Preventive Actions