Microsoft Word and Excel in FDA Regulated Industries: Pack of Four Training Courses

This pack of four training courses provides 4 hours of traning on validation and use of Microsoft Excel Spreadsheets, good documentation practices, using Styles in Microsoft Word, and reducing the cost of creating documents in FDA Regulated Industries.

Instructor: Dr. Ludwig Huber

FDA Regulations require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. This seminar will demonstrate how FDA compliance requirements can be met for Excel Spreadsheet applications.

Microsoft 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® the requirements can be met. This seminar will demonstrate how FDA compliance requirements can be met.

Module 2: Introduction to Good Documentation Practices for FDA-Regulated Industries

Instructor: Chris Whalley

Good Documentation Practices are the set of activities that enable you to record your raw data and hand-written entries in a legible, traceable and reproducible manner. Compliance with FDA`s GLP regulations (21 CFR Part 58), as well as GMP regulations (21 CFR Part 211), requires the use of Good Documentation Practices.

This seminar is intended to introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

Module 3: Introduction to Styles in Microsoft Word for FDA Regulated Industries

Instructor: Chris Whalley

If you`re like most people in regulated industries, you use Microsoft Word software to create and edit policies, procedures and other compliance documents. Despite the widespread use of Microsoft Word software, the most important feature of Word continues to confuse and intimidate users... Styles. Since Word applies styles to everything you put in your documents, learning how to use styles properly has enormous benefits including, saving time when creating or editing documents
creating more consistent, professional-looking documents, increasing the stability and efficiency of your electronic document files, improving conversion from Word to other file formats, such as PDF and HTML.

Module 4: Reducing the Cost of Creating Documents for FDA-Regulated Industries

Instructor: Chris Whalley

This seminar covers how to streamline the process of creating policies and procedures to reduce costs, optimize labor, improve quality and, ultimately, improve FDA compliance. Organizations seeking to improve quality, productivity and compliance in their FDA-regulated activities must streamline the process of creating policies and procedures. This seminar will explain how to measure and reduce the FDA recordkeeping burden.