How to Transition from Paper to Electronic Records in a Regulatory Environment 2015

Topics

• Records data map
• Records policy and procedures
• Converting paper documents into a useful electronic format
• Incorporating paper records into a eCTD
• Indexing and organizing scanned records and integrating them
• Scanning costs and resources
• Big data – implications to the drug business
• Long term record storage and retrieval

Who should Attend

Personnel from pharmaceutical and clinical trial companies, involved in:

• Scientists
• Research & Development
• Clinical Research (project managers, investigators, study coordinators, operations, QA and document managers)
• Regulatory Affairs
• Information Technology
• Legal
• Documentation
• Validation