Validation and Control of Excel® Spreadsheets in Regulated Environments

  • Speaker:Ludwig Huber
  • Date: 29th June 2017 10:00 AM PST | 01:00 PM EST
  • Duration:75Min
  • Product Code:GRC-90150

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Description:

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.
Topics :

    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

Hand-outs :

For easy implementation, attendees will receive

    SOP: Validation of spreadsheet applications
    SOP: Development and use of spreadsheets in regulated environments
    Gap analysis/checklist for Macros and Spreadsheet applications

Who will benefit :

    Developers and users of spreadsheet templates
    Lab Supervisors and managers
    QA managers and personnel
    Analysts
    Consultants
    Teachers

Target Companies :

    Pharmaceutical
    Manufacturers of Pharmaceutical drug substances (APIs)
    Contract laboratories
    Medical device companies
    Clinical testing
    CROs

Instructor Profile :

Ludwig Huber, Ph.D., is the director of Lab compliance and  editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, , ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website www.ludwig-huber.com.

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