February 2013

Presenter:  Brandon Giosiengfiao

Location: Temecula City Library

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Start Date: February 21st, 2013
Start Time: 6:00 pm
Price: $ 20.00 – 25.00

Title: Part 11 compliance requirements in pertaining to Excel Spreadsheets


Member: $20.00, Nonmember: $25.00
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Part 11 compliance requirements in pertaining to Excel Spreadsheets and its intended use to make quality decisions on product.


For medical devices regulated by FDA 21 CFR Quality Systems, section 820.70 states “Production and Process Controls for automated processes, “When Computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

Example of a 3rd Party Audit observation and electronic records used for quality decision making.

This type of observation results as a finding and deemed critical for corrective action.

Presentation will discuss the following and learning outcomes:

  1. Audit finding resulting in project
  2. Components of Part 11 as it relates to Excel SS and intended application
  3. How to identify XL SS used in your company
  4. Determining XL SS that will require full validation versus non validation using risk base approach
  5. Option to use consultant or do yourself approach if you currently have a validated business system.
  6. The sequence order of validation as it relates to documentation
  7. Releasing records in your document control
  8. Training
  9. Monitoring system for continuous improvement
  10. Readiness to the follow up audit

Speaker Bio:

Brandon Gosiengfiao currently works for Boston Scientific formerly Cameron Health in San Clemente as a Senior Quality Engineer. Brandon has worked as a Quality Engineer for medical device companies since 2000. Former companies include Guidant, Abbott Vascular, ExtruMed, Cardinal Health and CareFusion.  Brandon has a BS in Business Management and Minor in Industrial Technology from San Jose State University. Brandon is also ASQ CQE Certified. Brandon currently resides in Temecula CA and has lived in Temecula since 2000. Brandon is married to Jeannie, who currently is General Manager for RSP & Associates in Temecula.  Brandon has 2 daughters, Alexandra, currently a Senior at Temecula Valley High School and Izabella, currently a Third Grader at Abby Reinke Elementary.  Brandon is currently an ASQ Member and attends the Temecula section.