Course "A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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.
This seminar gives guidance on how to achieve compliance for Excel spreadsheets and other end user applications, such as small databases, in a GxP environment. While the examples given in this seminar are mainly spreadsheets, the same principles can be applied to other end user applications.
Spreadsheets are available for creating a wide range of end user applications, including 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 they 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.
This is then coupled with the fact that it is easy to build spreadsheet applications without much training has resulted in spreadsheets being among the most under-documented systems used in GxP environments.
users regard them as part of the desktop
the ease with which applications can be built without much training
the data processing power that they can have
Consequently, spreadsheets are "low hanging fruit" as part of FDA or other regulatory inspections, and many Warning Letters have been issued.
The level and rigor of specification and verification applied to spreadsheets should be based on risk, complexity, and novelty. This seminar provides guidance on
What to do to create the validation deliverables required to ensure GxP Compliance for Excel
How to tailor a risk based methodology to excel to help determine the appropriate validation approach.
Agenda:
Day 1 Schedule
Lecture 1:
Types of Spreadsheets
Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Types of Excel Spreadsheets
Uses of Excel Spreadsheets
Lecture 2:
Excel Validation at a High Level
21 CFR 11 / Annex 11 & CSV - Basic Concepts
CSV components and deliverables
Lecture 3:
FDA Use of Excel Spreadsheets
GxP Compliance for Excel - an FDA Perspective
FDA Use of Compliant Excel Spreadsheets - an FDA Case Study
Lecture 4:
Excel Validation Master Plan (VaMP)
Validation Inventory
Determining need for GxP Compliance
Excel Validation Master Plan Standards
Exercise to create Excel Validation Master Plan
Day 2 Schedule
Lecture 5:
Excel Risk Assessment & Requirements
Risk Assessment
Tailoring Risk Methodology to Excel
Validation Plan
Requirements Specifications
Exercise on how to create Excel requirements
Lecture 6:
Excel Functional & Design Specification
Functional & Design Specifications
Software Configuration and Build
Exercise on how to create Excel Design Specifications
Lecture 7:
Verification & Testing for Excel CSV
Traceability Matrix
Verification and Testing
Exercise Creating Excel Validation Scripts
Validation Report
Validation Registry
SOPs
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.xperience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers.
Location: Baltimore, MD Date: August 16th & 17th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price:
Price: $1,295.00 (Seminar Fee for One Delegate)
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)
Until July 20, Early Bird Price: $1,295.00 From July 21 to August 14, Regular Price: $1,495.00
Sponsorship Program benefits for seminar
For More Information- https://www.globalcompliancepanel.com/control/sponsorship
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