Spreadsheets for GxP Environments

Course Aims:

Did you know that the FDA uses spreadsheets within in its own laboratories and have their own internal guidance on designing and validating spreadsheets? Many companies use spreadsheets for GxP activities but fail to validate them. When appropriately designed and validated spreadsheets can be a very simple and useful tool in the GxP environment. This training course aims to provide participants with the necessary skills to design and validate spreadsheets for GxP environments that meet the needs of regulatory bodies such as the FDA.

Course Content:

Uses of Spreadsheets in the GxP Environment

Types of Spreadsheets
When to use/not use a spreadsheet for managing GxP activities
Inventory of GxP Spreadsheets
GAMP5 Categorisation of Spreadsheets
Risk

Validation Documentation

Validation Planning
User Requirements
Functional/Design Specifications
Validation Protocols - IQ, OQ, PQ
Validation Reporting

Design Considerations

Spreadsheet Layout
Formulas
Macros
Controls and Checks
Protection
User Interface
Security
Electronic Records

Training Duration : 0.5 day

Training Methods: This workshop uses a combination of slide presentation and other multi-media to introduce key concepts. The course will also involve interactive discussion and practical examples. Each participant will be provided with a Training Manual, Validation Document Templates and Sample Spreadsheets.

Target Trainee Profile: This course is aimed at personnel involved in the development and validation of spreadsheets within a GxP environment including Quality and IT and others within the Pharmaceutical, Medical Device or Biotechnology Industries.

Public Course Cost : €200 per person includes course documentation, templates, lunch and refreshments

Note: This course can be arranged specifically for your company. Please contact us if we can assist you with any enquiries in regard to the next public course or if you would like us to arrange a course for you.