Computer System Validation Course

Computer System Validation – CSV
for Industry Professionals

Start learning how to apply CSV regulations to your current projects immediately!
  • WSQ Accredited as (Manage Electronic Data for Computer
    System Validation PI-PH-405E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: 5th June

Computer System Validation – CSV
for Industry Professionals

Start learning how to apply CSV regulations to your current projects immediately!
  • WSQ Accredited as (Manage Electronic Data for Computer System Validation PI-PH-405E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: 5th June
Computer System Validation
Computer System Validation Course
Computer System Validation Course
Computer System Validation Course
Computer System Validation Course
Computer System Validation Course

Advanced

Join 2,381 Learners

Online, 10 weeks

14 hrs / week

Apply Now

What this course will teach you:

Understand the CSV Process

Get a thorough understanding of how the CSV process fits into your software life cycle and the purpose of each validation deliverable.

Create Key Validation Deliverables

Practice creating key validation deliverables such as GAMP 5 Software Categories and Life Cycle Phases, 21 CFR Part 11, Electronic Records and Electronic Signatures.

Manage Auditors’ Expectations

Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations.

Apply Regulations to Your Projects

Apply the FDA and international regulations and guidance regarding CSV on your current company projects.

Use Best Practices

Get the best practices for validation test execution, documentation, and error handling.

Apply Risk Based Decision Making

Use risk-based decision making in your software quality assurance procedures.

This Course is Right For You If;

  • You already have a basic understand of computer system validation including GAMP 5 and 21 CFR Part 11
  • Need to apply these concepts at work in a daily basis
  • You have direct experience working in an FDA regulated environment
  • You need an Advanced Course that goes deep into this subject
  • You don’t want to waste time or money on hotel or travel fees.

This course is probably not for you, if

  • You have never worked in the pharmaceutical or medical device manufacturing industry.

How does Studying Online Work?

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
Online courses can start off great, but staying motivated can be a challenge. So, you’ll get regular feedback reports (and emails or phone calls if you fall behind!) to keep you on track.
Because it’s online, there are no long commutes, traffic jams or crowded trains to deal with on the way to class. Study at home after the kids have gone to bed.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.
Hear From People Who’ve Taken This Course
Pharmaceutical Manufacturing

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Pharmaceutical Manufacturing

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Your Lecturer

Computer System Validation

Dr. Joe Brady

Lecturer, Dublin Institute of Technology

Dr. Joe Brady is an assistant lecturer with the Dublin Institute of Technology (DIT), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer, and highly experienced in competency based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.

He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

Your 10-Week Class Schedule

Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.

And he or she will proactively follow up with you to keep you on track.

Download Brochure

Week 1 – Software Categories, Life Cycle Phases, and Operational Activities

  • Drivers for GAMPS.
  • GAMP 5 Software Categories
  • Operational Activities
  • Life Cycle Phases of Computerized Systems
  • Computerized Systems in Regulated GxP Environments
  • Handover
  • Product and Process Understanding
  • End User Activities

Week – Record Anatomy and Data Flow Analysis

  • Electronic Record Content, Structure and Context, and Record Anatomy
  • Records and Signatures required by 21 CFR Part 211
  • PLC Controlled Packaging Equipment
  • Supervisory Control and Data Acquisition (SCADA)
  • Data Flow Analysis
  • Example Records and Signatures Required by ICH Q7

Week 3 – Science Based Quality Risk Management and Validation Planning

  • Supplier Activities
  • Validation Planning
  • Science Based Quality Risk Management
  • Risk Management Considerations Generic Hazards
  • Requirements Traceability Matrix (RTM)
  • Efficiency Improvements (Continuous Improvements)
  • Categorization of Laboratory Computerized Systems

Week 4 – Identify Regulated Records and Signatures, and Impact Assessment of Electronic Records

  • HPLC System
  • Chromatography Data System (CDS)
  • GxP Records and Signatures Required by 11 CFR Part 820
  • Prerequisites for Good Electronic Records Management
  • Laboratory Information Management System (LIMS)
  • Identify Regulated Records and Signatures
  • Electronic Production Records (EPR)
  • Impact Assessment of Electronic Records
  • Spreadsheets

Week 5 – Specification and Verification, Scalable Validation Deliverables and Configuration Management

  • Organizational Change
  • Outsourced IS/IT Environment
  • IT Compliance
  • Development versus Implementation Life Cycle
  • ASTM E 2500 – 07
  • Testing Documentation Structure & Verification Terminology
  • Scalable Validation Deliverables
  • Patch and Update Management
  • Operational Change and Configuration Management
  • Repair Activity
  • Periodic Review
  • Backup and Restore

Week 6 – Good Electronic Records Management Transactions, and Audit Trails

  • Good Electronic Records Management Transactions
  • Audit Trails
  • AutoCAD Used For Managing Pack Drawings
  • Building Management Systems (BMS)
  • FDA Predicate Rule 21 CFR Part 211 – Subparts D and J
  • FDA 21 CFR Part 11 – ‘Electronic Records; Electronic Signatures’ (ERES)

Week 7 – Electronic Data Archiving, Business Continuity Management, and System backup, Archival, and Disaster Recovery

  • Electronic Data Archiving Part
  • Typical Tasks Supporting Validation (B)
  • Security Management
  • Business Continuity Management
  • System Retirement Decommissioning and Disposal
  • Copies of Records

Week 8 – Controls to Maintain Electronic Record Integrity, and Risk Controls for Electronic Signatures

  • Complying with 21 CFR Part 11 ERES – Types of Controls Required
  • Complying with 21 CFR Part 11 – Key Areas for Guidance
  • Batch Record System
  • Enterprise Resource Planning (ERP) Systems
  • Controls to Maintain Electronic Record Integrity
  • Risk Controls for Electronic Records
  • Risk Controls for Electronic Signatures
  • User ERES Responsibilities
  • Supplier ERES Responsibilities

Week 9 & 10

Competency Based Assessment

The end of module assessment is a competency based open book exam where you will need to answer 8 essay style questions. Each essay will require about half a page to one page to answer. Your answer will be assessed as either competent or not yet competent. In addition, you will also have a 15 minute oral interview with our Subject Matter Experts.

Complete the Following Activities & Workshops

You will produce a number of deliverables during the course including:

  • Determine the end user supplier activities during the lifecycle of a computerized system
  • Identify where you would use risk based decision making throughout the lifecycle of a computerized system
  • Prepare a Configuration Management Process Flow Diagram and identify where to use Change Control
  • Define the content of typical logs and accompanying records for both incident Management and corrective and preventive action (CAPA)
  • Determine suitable risk controls when assessing electronic records and electronic signatures.

Accredited under the WSQ Program

This module is accredited under the WSQ programme as (Manage Electronic Data for Computer System Validation PI-PH-405E-1) subject to the following criteria. Passing a written and oral Exam on the materials.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete your competency based assessment and the end of module interview webinar to get your WSQ Certificate.

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

image-of-Computer-System-Validation–CSV-course-dpseducation

Price

S$499/month

For 3 Months

S$1,347 in Advance

Save S$150

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Application Deadline: 5th June, 2019

Course Starts: 13th June

0
0
0
0
Days
0
0
Hrs
0
0
Min
0
0
Sec

Start Your Application

Click below to start your application.

Apply Now

Contact Us

Singapore
Call Geraldine: +(65) 6513 9500

Got More Questions?

My Name*

My Email*

My Message*

 

Frequently Asked Questions

This is an advanced and high level course and is not comparable to a two day course both in the range of content covered and the detail it goes into. Furthermore, spreading the learning over 10 weeks rather than trying to cramp everything into a three day or one week event means that you will dramatically improve your retention of the materials.