2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018

By: Angela Bazigos, CEO Touchstone Technologies Silicon Valley.
Product code: SEM29
Location 1: Washington DC Jul 19 - 20

Description

Course “FDA 21 CFR Part 11 Compliance – Validation Seminar 2018“ has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS. "

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:

        •       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
        •       lack of knowledge that spreadsheets need to be validated
        •       lack of knowledge on how to validate spreadsheets

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

Areas Covered

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

•      VP of IT
•      Director of IT
•      Quality Managers
•      Project Managers (for CSV / IT)
•      Validation Specialists
•      Database Administrators
•      System Administrators
•      Directors / Senior Directors of Discovery
•      Directors / Senior Directors of Development
•      Directors / Senior Directors of Commercialization
•      Document Managers
•      Training Managers
•      Regulators

Learning Objectives

This 2 Days Workshop is intended for professionals in the 
•  Pharmaceuticals
•  Biotech
•  Medical Device
•  Radiological Health
•  Blood Products
•  Companion Animals
•  Food
•  Cosmetics
•  Tobacco
•  Academia Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Course Outline:

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

Lecture 8: Quality Assurance for Excel CSV

        •    How to audit Excel CSV projects
        •    Excel 483s and Warning Letters
        •    Excel Validation Jeopardy!!!

 

speaker

Angela BazigosCEO Touchstone Technologies Silicon Valley

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

19-July-2018 To 20-July-2018 Washington DC
Seminar One Registration
$ 1295



Special Group Discount Register for Four attendees
$ 3995

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 10% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

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Hilton Garden Inn Washington DC / U.S. Capitol 
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How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

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