Validation & 21 CFR 11 Compliance Of Computer Systems
This seminar teaches participants how to include 21 CFR 11 requirements in Computer Systems Validation (CSV).
- San Francisco, CA (1888PressRelease) July 24, 2014 - Summary: GlobalCompliancePanel will organize a RAPS-preapproved two-day, in-person seminar in Burlingame, CA on the topic, "Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems" on July 24 and 25 (Thursday and Friday). Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc. will be the speaker at this two-day session.
The course, "Advanced Course: Validation & 21 CFR 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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Venue, date and timings: The venue for this seminar, which will be on July 24 and 25 (Thursday and Friday), from 9 AM to 6 PM EDT, is Hotel DoubleTree by Hilton Hotel San Francisco Airport, 835 Airport Blvd., Burlingame CA 94010-9949.
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What the seminar is about:
This seminar teaches participants how to include 21 CFR 11 requirements in Computer Systems Validation (CSV).
Computer Systems Validation (CSV), also known as Software Validation is critical and all-pervasive in the Life Sciences industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, one needs to really know how to implement CSV, without which it is often very hard to detect the requirement for CSV. This knowledge gap makes it very hard to determine what needs to be done, to meet domestic and/or international regulations or business continuity requirements. Another component that has made this task all the more difficult is that the FDA has stepped up 21 CFR 11 inspections that include CSV.
This seminar will be useful in helping participants understand the finer elements of 21 CFR 11 requirements in CSV. The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system.
The speaker will cover the following areas:
-Validation Master Plan
-Complete Validation for a System
-Excel Spreadsheet Validation
-Change Control
-SOPs
- Test Tools Validation
- Project Management for Validation
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About the Speaker:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years' experience in the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and conducts classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management.
More recently, Ms. Bazigos was selected to co-author Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia.
Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.
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The agenda:
The seminar will have the following agenda:
Course Description:
Day 1
Lecture 1:
Lecture 1: Introduction/Background
• Introductions/Participants' Understanding
• Participants' Objectives for the Course (Please come prepared to discuss)
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Lecture 2: Requirements at a High Level
• Types of Requirements
• Difference between User Requirements & Functional Requirements
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Lecture 3: Detailed Requirements Study
• Gathering Requirements
• Entity Relationship Diagram
• Process Decomposition
• Risk Assessment for Requirements
• Exercise on how to create Requirements
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Lecture 4: Design
• Design Specifications
• Software Configuration and Build
• Exercise on how to create Design Specifications
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Day 2
Lecture 5: CSV Detailed Study (Cont'd)
• Traceability Matrix
• Verification and Testing
• Exercise Creating Validation Scripts
• Exercise Creating Traceability Matrix
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Lecture 6: Other Documents
• Validation Plan
• Test Protocols
- Test Reports
• Validation Report
• Validation Registry
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Lecture 7: Special Topics
• Project Management for CSV
• Infrastructure for CSV
• Selecting software for 21 CFR 11 Compliance
• Test Tools for CSV
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Lecture 8: Change Control & Business Continuity
• Change Control
• Implementing Business Continuity for CSV
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For whom:
This seminar 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
This hands-on training session will benefit professionals in the following industries:
- Pharmaceuticals
- Biotech
- Medical Device
- Radiological Health
- Blood Products
- Companion Animals
- Food
- Cosmetics
- Tobacco
- Academia
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About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing/Clinical/Lab), EU and ISO.
These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel's trainings are focused, flexible and tailored to the client's need.
This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel's seminars have helped participants reach their career milestones. In bringing globally renowned experts in the field of regulatory compliance and executives in the industry together, GlobalCompliancePanel fosters a learning experience. With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields.
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Price:
Register now and save $200. (Early Bird)
Until July 11: Early Bird Price: $1,295.00
From July 12 to July 22: Regular Price: $1,495.00
Discounts are available for group participation in the following manner:
For two attendees: 10% discount
For three to six attendees: 20% discount
For seven to 10 attendees: 25% discount
For more than 10 attendees: 30% discount
To avail the above group discounts, all the participants should register by making a single payment.
Please note that the registration will be closed two days (48 hours) prior to the start date of the seminar.
Call our representative on 1800 447 9407 to have your seats confirmed.
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Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
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