Training Course Syllabus:

Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

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:

Validation Master Plan
Complete Validation for a System
Excel Spreadsheet Validation
Change Control
SOPs
Test Tools Validation
Project Management for Validation

This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools

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

Industries:

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

Agenda:

Day 1 Schedule:

Lecture 1:
Introduction / Background

Introductions / Participants´ Understanding
Participants´ Objectives for the Course (Please come prepared to discuss)

Lecture 2:
Requirements at a High Level

Types of Requirements
Difference between User Requirements & Functional Requirements

Lecture 3:
Detailed Requirements Study

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

Lecture 4:
Design

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

Day 2 Schedule:

Lecture 5:
CSV Detailed Study (Cont´d)

Traceability Matrix
Verification and Testing
Exercise Creating Validation Scripts
Exercise Creating Traceability Matrix

Lecture 6:
Other Documents

Validation Plan
Test Protocols
Test Reports
Validation Report
Validation Registry

Lecture 7:
Special Topics

Project Management for CSV
Infrastructure for CSV
Selecting software for 21 CFR 11 Compliance
Test Tools for CSV
Lecture 8:
Change Control & Business Continuity

Change Control
Implementing Business Continuity for CSV

Speaker:

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.

Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry.

Seminar Summary:

Computer Systems Validation (CSV) also known as Software Validation is 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, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. (see full course description)

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