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Computer System Validation Course

Computer System Validation – CSV
for Industry Professionals

Start learning how to apply CSV regulations to your current projects immediately!
  • High level course for those serious about roles using CSV
  • Part-time, Online. Study from anywhere
  • No Needless Travel or Overnight Stays
  • Get an Advanced CSV Certification
  • Course Starts: July 6th
Price €1,499
Price €2,299
Price $2,499

Computer System Validation – CSV
for Industry Professionals

Start learning how to apply CSV regulations to your current projects immediately!
  • High level course for those serious about roles using CSV
  • Part-time, Online. Study from anywhere
  • No Needless Travel or Overnight Stays
  • Get an Advanced CSV Certification
  • Course Starts: July 6th
Price €1,499
Price €2,299
Price $2,499
Computer System Validation
Computer System Validation Course
21 CFR Part 11
Electronic Data Archiving Part
Good Electronic Records Management Transactions
Record Anatomy and Data Flow Analysis

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?

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
Drivers for GAMPS.

Ken O’Keeffe

“Interesting and Helpful in my Current Role”

“I have found the Computer System Validation course to be both interesting and helpful in my current role. The individual sections of the course are easy to follow. The delivery of the course is really straight forward. During the course there has been times when I have been busy with work and have not been able to study. The structure of the course allows me to be flexible in my study.”

Computer System Validation Course

Giorgia Romeo

“I Would Highly Recommend This Course”

“I would highly recommend anyone wishing to gain an education in the Computer System Validation sector to do this course. For me it has been very useful studying on-line in order to do the course in my own time. Lessons are very clear and the assignment deadlines make you disciplined to meet the deadlines set.”

Computer System Validation

John Ryan

“The Course Material is Concise and Interesting”

“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”

Your Lecturer

Our Team

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.

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

Complete an End of Module Assignment

Prepare a report to identify different types of computerized systems and explain how from data-flow analysis potential source of undesired events or where record integrity could be compromised? Then specify an electronic record for one system and the main categories of controls to maintain its integrity and compliance to 21 CFR Part 11 and the signatures required by 21 CFR Part 211, 21 CFR Part 820 and ICH Q7.

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.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete a written assignment to get certified in Computer System Validation

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

Computer System Validation Course

Price

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