Course "Validation and 21 CFR Part 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.

Overview:

The Problem

We have all heard of Computer Systems Validation & Data Integrity, but do you really understand what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture? Specifically, can you answer questions on the following:

21 CFR Part 11 and Computer Validation: Why so many citations?
Computer Systems Validation (CSV) and 21 CFR 11 vs Annex 11
Data Integrity vs Computer Systems Validation
Overview and Key Requirements of Part 11 & CSV
How to use a Risk Based Assessment to reduce work while still achieving Compliance?
How FDA & other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

I often refer to 21 CFR 11 and CSV as Good Software Engineering with the Documentation on Steroids! However, unless one knows how to implement CSV, it is very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the agencies have stepped up computer validation inspections and the number of citations on the subject are skyrocketing!

This course is appropriate for the beginner and the experienced person alike. The topics will build on each other and will give you the latest trends in our heavily regulated industry and how to make it easy for yourself while still achieving data integrity.

This is a very hands-on class and the attendees will be given take away templates that will enable them to build a complete package to meet Data Integrity Requirements for Computerized Systems.

The Seminar

This hands-on course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with Computer Systems Validation as follows:

What is 21 CFR 11/Annex 11 and Computer Systems Validation and how is it implemented
How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
Data Integrity Frequently Asked Questions
Validation Master Plan
Risk Based Assessment
Complete Validation for a System (software development lifecycle)
Equipment Qualification
Infrastructure Requirements
Change Control
SOPs

Who Should Attend:

VP of IT
Director of IT
Quality Managers
Project Managers (for DATA INTEGRITY / 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
Consultants
Data Managers
Safety Managers

Industries:

Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Hospitals
Healthcare
Companion Animals
Food
Cosmetics
Tobacco
Academia
Agricultural

Agenda:

Day 1 Schedule

Lecture 1:
21 CFR 11 & Annex 11

Introductions / Participants' Understanding
Participants' Objectives for the Course (Please come prepared to discuss)
21 CFR 11 / Annex 11
21 CFR 11.10(a) - Computer Systems Validation

Lecture 2:
Data Integrity

What is Data Integrity
How does it fit with 21 CFR 11
FDA's latest guidance

Lecture 3:
Risk Assessment & Vendor Audits

Vendor Audits
Risk Assessment for the System
Risk Assessment for Requirements

Lecture 4:
Requirements

Gathering Requirements
Entity Relationship Diagram
Process Decomposition
Exercise on how to create Requirements

Day 2 Schedule

Lecture 5:
Design

Design Specifications
Software Configuration and Build
Exercise on how to create Design Specifications

Lecture 6:
Verification & Testing

Traceability Matrix
Verification and Testing
Other Documents
Exercise to create Test Cases

Lecture 7:
Special Topics

Equipment Qualification
Infrastructure Requirements

Lecture 8:
Change Control & SOPs

Change Control
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 http://morflearning.com/angelabazigos/. Experience 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. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Location: SFO, CA Date: August 9th & 10th, 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 now and save $200. (Early Bird) Until July 10, Early Bird Price: $1,295.00 From July 11 to August 07, Regular Price: $1,495.00

Sponsorship Program benefits for seminar

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

NetZealous LLC DBA GlobalCompliancePanel

[email protected]

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

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