ComplianceOnline

Use of Spreadsheets to Report Data in FDA Regulated Industries

Instructor: Robert Ferer
Product ID: 701298
  • Duration: 60 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: May-2009

Training CD / USB Drive

$500.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Spreadsheet validation training 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.

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.

Follow us :
Upcoming In-person Seminars by EX-FDA OFFICIALS
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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