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
Documentation
- Meeting the Regulatory Expectations -
A 2-Day Intensive Continuing Education Course 1.2 CEU's)
Course Faculty: Frieder
K. Hofmann, Ph.D.
Course Content:
Why Documentation
Proof of Invention
Company Operations
Technology Transfer
Regulatory Requirements
Liability Protection
The Documentation System
What needs to get documented?
What should get documented?
Ensuring Comprehensive Documentation
Avoiding Contradiction in Documents
Document Control
The Regulatory Expectations
R&D Documentation
GLP Documentation
GMP Documentation
Implementation of a New Documentation System
Augmentation of Existing Documentation System
The Documentation Hierarchy
Commitment Documents
Policies
Plans
Contracts
Directive Documents
Specifications
Standard Operating Procedures (SOP's)
Production Batch Record
Master Device Record
Validation Protocols
Notebooks
Data Collection Documents
Production Batch Record
Device History Record
Quality Control Records
Validation Records
Equipment and Facility Logbooks
Calibration and Maintenance Records
Vendor History File
Inventory Cards
Reports
Study Reports
Development Reports
Process Flow Diagrams
Validation Reports
Facility Qualification Report
Content and Format of the Different Types of Documents
Document Design
Electronic Documentation and Compliance with 21 CFR Part 11
Copyright Center for Continuous Education