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. For easy implementation, attendees will receive: User Manual with Excel functions that help to comply with FDA requirements SOP: Validation of spreadsheet applications SOP: Development and use of spreadsheets in regulated environments Gap analysis/checklist for Macros and Spreadsheet applications Areas Covered in the Session : Regulatory requirements for spreadsheets; FDA Part 11 and GxP Recent FDA inspectional observations and warning letters Recommendations from the new GAMP®5 and EU Annex 11 How to design spreadsheets for compliance. How to design, 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 Should Attend: Everybody developing and using Excel Worksheets for regulated environments Developers and users of spreadsheet templates Lab Supervisors and managers QA managers and personnel QC managers and personnel IT managers and personnel Analysts and lab managers Validation groups Training departments Documentation department Consultants Teachers


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Areas Covered in the Session :

  • Review the current regulatory requirements and guidances (CFR, EU GMPs, ISO, etc.) for environmental monitoring.
  • Discuss issues of sampling methods, selection of sampling sites and the justifications for them.
  • Review the issue of contamination control as an important aspect of EM programs.
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions.
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?
  • Attendee question and answer period.

Who Should Attend:

  • QA/QC Teams
  • Manufacturing Teams
  • Engineering Teams
  • Validation Teams
  • Regulatory affairs Teams
  • Management Teams
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