Use of Spreadsheets to Report Data in FDA Regulated Industries

Spreadsheets are widely used in the pharmaceutical and biotechnology industry as an easy means to view large amounts of data. What many firms don't realize is that depending upon how the spreadsheets are used, they require validation to demonstrate that the data upon which quality decisions are being made, is reported accurately and reproducibly. This course will provide the necessary information to allow your organization to determine the appropriate amount of testing necessary, as well as how to design, use, and organize the spreadsheet to report the data in a useful manner.

This course will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use. In addition, useful tools to report and view the data will be demonstrated.

Areas Covered in the seminar:

• Understanding of user requirements specifications, and why they are critical.
• Background of GAMP categories and validation requirements.
• Understanding of the validation process.
• Detailed understanding of how to create a user friendly spreadsheet (creation and modification).
• Functions of spreadsheets that are useful for reporting and securing data.
• Ways to display the data to allow ease of interpretation.

Who will benefit:

The course will be presented in a manner to allow each attendee to quickly put to use the features, functions, and ideas covered in the seminar and they will be able to generate spreadsheets that are well designed and easy to validate. The course will provide an immediate benefit for:

• Laboratory analysts (chemists and microbiologist)
• Laboratory supervisors and managers
• Validation technicians
• Anyone who uses spreadsheets to present information

Instructor Profile

Robert Ferer, is President and founder of The Ferer Group Inc. A graduate of the State University of New York at Stony Brook, Bob is an engineering chemist and has more than 19 years direct industry experience including the design, build, start-up, and management of facilities, specializing in aseptic manufacturing. His expertise ranges from developing and executing project master plans, schedules, and budgets to performing hands-on validation, design review, and equipment start up and commissioning. A natural leader and mentor, he presents courses as well as contributes to industry publications.

To further develop his awareness of the pharmaceutical and biotechnology industries’ advancements, Bob is an active member of the International Society of Pharmaceutical Engineers and the Parenteral Drug Association. Bob frequently managed large projects and was instrumental in providing high-level consultation to clients. This included due diligence, facility audits, PAT implementations, and technology transfer. In his role as a leader, Bob recruited, trained and developed his staff to maintain the required expertise to support the industry.

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