GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
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Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements

Start Date : November 15, 2018
End Date : November 16, 2018
Time : 9:00 am to6:00 pm

Phone : 18004479407
Email : globalcompliancepanel@gmail.com

Location :
Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

Website

Description

 


Course "Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


Description:


Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.


GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.


This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:



Consequently, Spreadsheets have become "low hanging fruit" during FDA or other regulatory inspections and many warning letters have been issued.




Areas Covered in the Session:


Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics:



  1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)

  2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)

  3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)

  4. The FDA's Perspective and Use of Spreadsheets

  5. Examples of Typical Approaches for Excel Validation

  6. How to tailor your risk based methodology to Excel to determine the level of validation required

  7. 483s and Warning Letters for Excel and other Spreadsheets

  8. Quiz: Test your understanding of Computer Systems Validation for Excel




Who will benefit:



Agenda:


Day 1 Schedule




Lecture 1: Types of Spreadsheets





Lecture 2: Excel Validation at a High Level





Lecture 3: FDA Use of Excel Spreadsheets





Lecture 4: Excel Validation Master Plan (VaMP)



 


Day 2 Schedule




Lecture 1: Excel Risk Assessment & Requirements





Lecture 2: Excel Functional & Design Specification





Lecture 3: Verification & Testing for Excel CSV





Lecture 4: Quality Assurance for Excel CSV



Speaker:


Angela Bazigos


CEO, Touchstone Technologies Silicon Valley


Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer.


 


Location:  Salt Lake City, UT Date: November 15th & 16th, 2018 and Time: 9:00 AM to 6:00 PM


Venue:  Hilton Garden Inn Salt Lake City Airport 4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA


 


Price:


Until October 10, Early Bird Price: $1,295.00 Price: $1,295.00 (Seminar Fee for One Delegate)


From October 11 to November 14, Regular Price: $1,495.00


Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*


Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*


Register now and save $200. (Early Bird)


Sponsorship Program benefits for seminar


For More Information- https://www.globalcompliancepanel.com/control/sponsorship


Contact us today!


NetZealous LLC DBA GlobalCompliancePanel


john.robinson@globalcompliancepanel.com


Toll free: +1-800-447-9407


Phone: +1-510-584-9661


 Website: http://www.globalcompliancepanel.com


 


Registration Link -  https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901888SEMINAR?seo


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Registration Info

 

https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901888SEMINAR?meetings4docs-nov-seo

Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous LLC - DBA GlobalCompliancePanel ,
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA., 161 Mission Falls Lane, Suite 216.

GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.

GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.

GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:

  • Risk Management
  • Regulatory Compliances
  • Corporate Governance
  • Quality Management
Tel: 18004479407
Email: globalcompliancepanel@gmail.com
Website: http://www.globalcompliancepanel.com


Event Categories: Business Practice and Health & Nutrition.




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