Effective Document Management for Pharma, Biotech & Medical Device

Course Description

Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this pharmaceutical document management course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.

This pharmaceutical document management course addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.

Agenda

• Review regulatory requirements for documentation.
• Review Industry standards
• 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
• Going electronic from a manual system
• Features of electronic record keeping
• Understanding e-system requirements: validation, security, accountability, and audit trails
• Standard Operating Procedures and other documents to support the system
• Consistency in format and terminology
• Training requirements and training documentation
• Remaining "inspection ready"
• Auditing the system

Who Will Benefit

Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions) should attend. This effective document management course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management.