Computer System Validation (CSV) Boot Camp – Day 1 of 3 days Intensive Training

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Computer System Validation (CSV) Boot Camp – Day 1 of 3 days Intensive Training

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Learning Objectives

To discuss how to identify “GxP” Systems.
To study the Computer System Validation (CSV) approach based on FDA requirements.
To analyze the System Development Life Cycle (SDLC) approach to validation.
To evaluate how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
To inspect the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches.
To discuss the importance of “GxP” documentation that complies with FDA requirements.
To inspect the regulatory influences that lead to FDA’s current thinking at any given time.
To analyze how to best prepare for an FDA inspection or audit of a GxP computer system.

Course Description

Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems to ensure product safety and effectiveness.

In the United States, for example, the FDA requires pharmaceutical companies to perform CSV for systems that support the production of the following products:

Pharmaceuticals
Biologicals
Medical Devices
Blood and blood components
Human cell and tissue products
Infant Formulas

Computer system validation is required when configuring a new system or making a change in a validated system. CSV processes should be based on applicable regulations and guidance, best practices for the domain, and the characteristics of the system being validated.

Following are the major topics covered on Day 1 of this CPE Webinar on Information Technology:

FDA Compliance
Computer System Validation Methods and Models
CSV Planning
System Requirements & Design

This CPE course is designed to completely immerse you in computer system validation (CSV). It delivers comprehensive details of the regulations impacting your systems and hands-on practice writing validation documents.

During boot camp, we will explore both a traditional waterfall approach to validation and a Computer Software Assurance (CSA) approach that is supported by FDA. CSA focuses on critical thinking and may be done according to an agile methodology, using automated testing to improve the speed and quality of the validation effort. We will highlight the key differences and what must be done to succeed with either of the two methodologies.

We will also discuss industry best practices and areas of potential confusion and risk. Both compliance with data integrity and 21 CFR Part 11, FDA’s guidance on electronic records (ER) and electronic signatures (ES) will be covered.

Boot camp is tough and challenging.

It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to keep interested high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises, and case studies keeps energy levels high and challenges the participants.

Webinar Qualifies For

6 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
6 General Credit for Accountant/Bookkeeper/Tax Professionals
6 CPE Credit for Certified Internal Auditors (CIA)
6 CPE Credit for Certified Fraud Examiner (CFE)
6 CPE Credit for Certified Information Systems Auditor (CISA)
6 CPE Credit for Certified Government Financial Manager (CGFM)
6 CPD Credit for Certified Information Technology Professionals (CITP)
6 CPE Credit for Certified in Risk and Information System Control (CRISC)
6 CE Credit for Certified Wealth Strategist (CWS)
6 CE Credit for Certified Fiduciary and Investment Risk Specialist (CFIRS)
6 CE Credit for Certified FP&A Professional (FP&A)

About Instructor

Carolyn Troiano

Account Executive, BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Additional Information

Duration

6 Hours

Course Level

Basic

Instructional Method

Group Internet Based

Pre-requisites

None

Advance Preparation

None

FAQ’s

Click Here to View

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Ratings and Review

5

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Linda Hagedorn, CISA, CDPSE, PMI-ACP

I had an excellent experience in this class. The instructor is a master with her subject, and her dedication to transferring the knowledge could be felt in the room. She was enthusiastic and powerful in her delivery, and yet gracious when a word or two needed to be changed. I was very impressed with her, and delighted with the material.

6 Credits

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Subject Area

Information Technology

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Computer System Validation (CSV) Boot Camp – Day 1 of 3 days Intensive Training

Course Details

Learning Objectives

Course Description

Qualifies for

Webinar Qualifies For

Presenter Details

About Instructor

Carolyn Troiano

Other Details

Additional Information

6 Hours

Basic

Group Internet Based

None

None

FAQ’s

NASBA APPROVED

Ratings and Review

5

Linda Hagedorn, CISA, CDPSE, PMI-ACP

Subject Area

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