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:
Why are Healthcare Products Regulated?
Development of the GMP Regulations in the U.S
European and Japanese GMP Guidelines
The Meaning of "current" in cGMP
Regulation of Healthcare Products
Product Life Cycle
Design Control
Manufacture of clinical supplies
Manufacture of approved products
Designing a cGMP-Supporting Quality System
Defining Goals
Development of Requirements for
- Product,
- Materials,
- Processes,
- Personnel and
- Facility
Development of Specifications
Development Test Methods
Implementation of the Documentation System
What needs to be documented?
Ensuring Comprehensive Documentation
The Document Hierarchy
- Commitment Documents
- Policies, Plans
- 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
Ensuring Accountability and Traceability
Document Control
Electronic Documentation
Validation and Qualification
Test Method Validation
Materials Qualification
Facility Validation
Utility Validation
Equipment, Software and Cleaning Validation
Operator Qualification
Process Validation
Documentation of Validation
Change Management
Change Prevention
- Calibration, Maintenance and Revalidation
- Auditing and Training
Controlled Change
- Criticality of Change
- Off-line Validation
- Acceptance Decision and Implementation
When things go wrong
- Out-of-Specification Results
- Customer Complaints
- Deviations
- Conducting Investigations
- Decision Power
- Implementation of Corrective Action
Regulatory Inspections
What to Expect, how to Prepare and how to Respond
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