DAY ONE

• Implied and explicit regulatory requirements for documentation
• Industry standards
• Documentation from discovery through marketplace
• Management support
• The documents you need to control, from source data to dossiers
• Components of document systems
• System administration
• Document review, approval, and revision
• Document distribution, retrieval, and archiving
• Determining "how it needs to happen here"

• Going electronic from a manual system
• Features of electronic record keeping
• Understanding e-system requirements: validation, security, accountability, and audit trails
• Validation documents
  Standard Operating Procedures and other documents to support the system
• Writing sound procedures
• Consistency in format and terminology
• Training requirements and training documentation
• Remaining "inspection ready"
• Auditing the system
• The system over time: anticipating change