Computer System Validation (CSV) Training Course for Industry Professionals

  • WSQ Accredited as (Manage Electronic Data for Computer System Validation PI-PH-405E-1)

  • Go Rapidly From Total Beginner to Advanced Level CSV Expert
  • Extend you or your team’s role into CSV projects
  • Application Deadline: Wednesday 8th September
  • Study Online 14 hrs/week
  • 1 Module over 10 Weeks
  • Join 2120 Learners
Computer System Validation (CSV) Training Course for Industry Professionals

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

Computer System Validation (CSV) Training Course for Industry Professionals

Start learning how to apply CSV regulations to your current projects immediately!

Computer System Validation (CSV) Training Course for Industry Professionals
  • WSQ Accredited as (Manage Electronic Data for Computer System Validation PI-PH-405E-1)

  • Go Rapidly From Total Beginner to Advanced Level CSV Expert
  • Extend you or your team’s role into CSV projects
  • Application Deadline: Wednesday 16th September
  • Study Online 14 hrs/week
  • 1 Module over 10 Weeks
  • Join 2120 Learners

Our learners work for the world’s biggest pharma and medical device companies

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GSK Logo
Lonza Logo
Pfizer Logo
Novartis Logo
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Our learners work for the world’s biggest pharma and medical device companies

Novartis Logo
GSK Logo
Lonza Logo
Pfizer Logo
Roche Logo
Amgen Logo

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

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.

What Does the Online Classroom Look Like?

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
How-does-Studying-Online-Work

Meet Your Online Classroom Support Team

When you learn at GetReskilled, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Lecturers

Safe Medicine Lecturers

Learn the systems, protocols, tools, vocabulary, and best practices from our Lecturer’s who have had decades of on the job experience.

Course Leaders

Safe Medicine Course Director

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Safe Medicine Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

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.”

Delivered by an Industry Expert

Dr.Joe Brady Lecturer

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, DPS Education

Dr. Joe Brady is a full-time practicing Validation Lead and an assistant lecturer with Technological University Dublin (TU Dublin), 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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

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

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  • 1.1 Drivers for Good Automated Manufacturing Practices
    In this lesson, we learn about the primary drivers behind the issuing of the Good Automated Manufacturing Practices guidance document and its focus.
  • 1.2 Life Cycle Phases of Computerized Systems
    In this lesson, we explore the lifecycle of a computerized system from its early specification to its retirement and upgrade.
  • 1.3 Computerized Systems in Regulated GxP Environments
    The objective of this lesson is to be able to describe a computerized system to a regulatory inspector to demonstrate the system is in control and fit for use.
  • 1.4 Good Automated Manufacturing Practices Software Categories
    In this lesson, we look at ways to categorize computerized system from infrastructural and off-the-shelf software to configurable and bespoke applications.
  • 1.5 Operational Activities
    In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
  • 1.6 Handover
    This lesson looks at ways to ensure that the environment into which the computerized system is to be received is prepared, to make sure that the system can be used and supported in a controlled manner.
  • 1.7 Product and Process Understanding
    This lesson makes recommendations about the application of subject matter expertise when supporting lifecycle activities for a computerized system amongst the end-user and the supplier.
  • 1.8 End-User Activities
    This lesson explains the responsibilities of the end-user when it comes to supporting the lifecycle activities for a computerized system.
  • 2.1 Record Anatomy
    In this lesson, we will describe the structure of a record in terms of the arrangement of data elements, and we will also discuss the ‘electronic record lifecycle.
  • 2.2 Records and Signatures required by 21 CFR Part 211 
  • 2.3 PLC Controlled Packaging Equipment
  • 2.4 SupervisoryControlandDataAcquisition(SCADA)
  • 2.5 DataFlowAnalysis
    In this lesson, we look at data flow analysis across systems to reveal where integrity could be compromised as the record lives in various computing environments associated with its creation, use, and retention.
  • 2.6 Example Records and Signatures Required by ICH Q7 
  • 3.1 Supplier Activities
    This lesson explains the responsibilities of the supplier when it comes to supporting the lifecycle activities for a computerized system.
  • 3.2 Validation Planning
    In this lesson, we look at corporate and site level policy documents that define a regulated company’s overall approach to computerized system quality and compliance.
  • 3.3 Science-Based Quality Risk Management
    In this lesson, we look at suggestions about where to apply risk management throughout the lifecycle of a computerized system and how to manage the process for various categories of systems.
  • 3.4 Risk Management Considerations – Generic Hazards
    In this lesson, we look at an approach to conducting risk assessments on computerized systems based on their impact on product quality, patient safety and data integrity. We also list generic hazards for a computerized system associated with physical/environmental conditions, hardware and software, and human-related.
  • 3.5 Requirements Traceability Matrix (RTM)
    In this lesson, we introduce the Requirements Traceability Matrix (RTM); an important project document for tracing all user requirements to design specifications and appropriate verification tests.
  • 3.6 Efficiency Improvements (Continuous Improvements)
    In this lesson, we look at suggestions on ways to improve efficiencies throughout the lifecycle of a computerized system.
  • 3.7 Categorization of Laboratory Computerized Systems
    This lesson explains the GAMP® system for categorizing Laboratory Computerized Systems.
  • 4.1 HPLC Systems 
  • 4.2 Chromatography Data Systems (CDS) 
  • 4.3 GxP Records and Signatures Required by 11 CFR Part 820 
  • 4.4 Prerequisites for GERM
  • 4.5 Laboratory Information Management System (LIMS) 
  • 4.6 Identify Regulated Records and Signatures
    In this lesson, we describe why only those records required to meet GxP regulations, or submitted to regulators, should be identified as regulated electronic records.
  • 4.7 Electronic Production Records (EPR) 
  • 4.8 Impact Assessment of Electronic Records
    This lesson classifies regulated electronic records as High, Medium, or Low based on an assessment of the potential impact of the record on patient safety or product quality.
  • 4.9 Spreadsheets 
  • 5.1 Organizational Change – Impact During Project Lifecycle
    This lesson looks at various ways to manage projects during episodes of major organizational changes.
  • 5.2 Outsourced IS/IT Environment
    Here we look at the contract considerations when we choose to outsource control of our IS/IT systems to a third-party vendor.
  • 5.3 I T Compliance – Key Concepts, and Infrastructure Elements
    In this lesson, we look at ways to standardize our IT Infrastructure Elements to facilitate and somewhat ‘modularize’ our compliance strategy.
  • 5.4 Development versus Implementation Life Cycle
    In this lesson, we describe how to implement various computerized systems based on their software category; where from a user’s perspective the lower categories require less vendor input and where the higher categories require more.
  • 5.5 Specification, Design and Verification
    In this lesson, we review the ASTM International standard E 2500 – 07 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’.
  • 5.6 Testing Documentation Structure & Verification Terminology
    In this lesson, we look at good practices regarding the organization of testing documentation on a project and we also examine legacy and modern terms for testing documentation used in the medicinal products’ industries.
  • 5.7 Scalable Validation Deliverables
    This lesson recommends a range of scaleable validation deliverables over the range of software categories where we see increasing intricacy with increasing category designation.
  • 5.8 Patch and Update Management
    In this lesson, we consider suitable management strategies for the implementation of software patches and upgrades to an existing computerized system operating in a regulated environment.
  • 5.9 Operational Change and Configuration Management
    This lesson describes how to manage the configuration of a computerized system in a regulated environment during the operation and maintenance phase and keep it current and relevant where we’re in a period of continuous change and upgrading.
  • 5.10 Repair Activity
    In this lesson, we discuss a process by which non-functional systems are returned to a functional state under the control of a repair activity procedure.
  • 5.11 Periodic Review
    In this lesson we’re going to look at a method to ensure a computerized system remains compliant with regulatory requirements throughout its operational life, remains fit for intended use, and continually satisfies company policies and procedures.
  • 5.12 Backup and Restore
    In this lesson, we describe a mechanism to protect electronic information assets against loss of original data and subsequent accurate restoration of assets when required.
  • 6.1 Good Electronic Records Management Transactions
    In this lesson, we look at current good practices associated with good electronic records management including transactions, audit trails, sequence checks, electronic signatures, and continuous session system access.
  • 6.2 Audit Trails
    In this lesson, we explore how the application of audit trails improve information quality and reduce information loss from activities such as overwriting of data attributes.
  • 6.3 AutoCAD Used for Managing Pack Drawings
  • 6.4 Building Management Systems (BMS) 
  • 6.5 21 CFR Part 211 – Subparts D and J
    In this lesson we look at the FDA’s predicate GMP rule 21 CFR Part 211 specifically Subparts D and J. Subpart D relates to ‘Equipment’ and how subpart J relates to ‘Records and Reports’.
  • 6.6 FDA 21 CFR Part 11 – ‘Electronic Records; Electronic Signatures (ERES)’ 
  • 7.1 Electronic Data Archiving
    In this lesson, we describe a suitable data archiving strategy for moving data that is no longer actively used in the active environment where it was created to a separate data storage area for long-term retention.
  • 7.2 Typical Tasks Supporting Validation
    Here we look at recommendations from the FDA regarding tasks that may support the validation of a computerized system in a regulated environment.
  • 7.3 Security Management
    In this lesson, we define the controls required for securing a computerized system in an operational environment.
  • 7.4 Business Continuity Management
    In this lesson, we discuss how to regain access to an IT system and its data following a disaster, and how to restore critical business processes following a disruption while continuing to provide products or services.
  • 7.5 Relationship Between System Backup, Archival, and Disaster Recovery
    In this lesson we look at the inter-relationship amongst the accurate and reproducible backing up of digital assets (data and software), the archiving of closed business transactions and master data relocation to an external system, and the regaining of access to an IT system (including software, hardware and data) following a disaster.
  • 7.6 System Retirement, Decommissioning and Disposal
    This lesson describes appropriate controls that need to be in place when removing a computerized system from day to day use through obsolescence or replacement.
  • 7.7 Copies of Records
    This lesson considers methods on how to preserve the content and meaning of an electronic record when making a copy.
  • 8.1 Complying with 21 CFR Part 11 ERES – Types of Controls Required 
  • 8.2 ERES – Key Areas for Guidance – Where to Apply Electronic Signatures
    This video explores examples of where to apply electronic signatures required by predicate rules and required by internal procedures.
  • 8.3 Batch Record Systems 
  • 8.4 Enterprise Resource Planning (ERP) Systems 
  • 8.5 Controls to Maintain Electronic Record Integrity
    In this lesson, we examine controls to maintain electronic record integrity when creating and
    storing records, transmitting records, and archiving records, and also controls for signature certification/ authentication and signature link integrity.
  • 8.6 Risk Controls for Electronic Records 
  • 8.7 Risk Controls for Electronic Signatures
    In this lesson, we look at risk controls for electronic signatures in terms of instruction for the information associated with a signed electronic record, e-signatures security certificates, and signature controls.
  • 8.8 User ERES Responsibilities
    In this lesson, we look at the end-user’s responsibilities associated with electronic records and electronic signatures.
  • 8.9 Supplier ERES Responsibilities
    In this lesson, we look at the supplier’s/vendor’s responsibilities associated with electronic records and electronic signatures.

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.

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.
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.

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Price

S$1,299/month

For 3 Months

S$3,499 in Advance

Save S$398

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

Application Deadline: Wednesday 8th September 2021

Course Starts: 16th September

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    Frequently Asked Questions

    We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

    You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

    Yes, this program is delivered fully online.

    Each week of online content typically includes 6-10 topics.

    Each topic includes:

    • A set of course notes – these provide additional depth to the video content.
    • Warm-up self-assessment question – to recap or activate any relevant prior learning.
    • A video – these are typically 5-10 minutes long and deliver 80% of the course content.
    • Post video self-assessment questions to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials.
    • Any follow up assessments or assignments.

    Most students report between 8-14 hours per week.

    No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

    Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

    Yes, this course is relevant to both the pharmaceutical and medical device industries.