Overview: This webinar details the regulation and how it applies to computerized systems.

Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity.

Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

What makes this session unique is the combination of step-by-step instructions and the hands on workings of each participant. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.

Overview: Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations.

Areas Covered in the Session:

• Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
  
• Recommendations from the new GAMP®5 and EU Annex 11
  
• How to design spreadsheets for compliance.
  
• How to ensure and validate spreadsheet integrity.
  
• When, what and how much to test?
  
• Validation of standard/native Excel functions?
  
• How to apply risk based validation to spreadsheet applications
  
• Validation of 'ad hoc' spreadsheet applications.
  
• How to document planning, specifications, installation, testing and changes
  
• Examples from manufacturing, laboratories and offices

Who Will Benefit:

• Everybody developing Excel Worksheets for regulated environments
  
• QA Managers and personnel
  
• QC Managers and personnel
  
• Analysts and Lab Managers
  
• Validation Groups
  
• Validation Professionals
  
• Training Departments
  
• Documentation Department
  
• Consultants