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 in Automation
  • Part-time, Online. Study from anywhere
  • Get an Advanced CSV Certification

Advanced

Join 2,381 Learners Worldwide

Online, 10 weeks, 14 hrs / week

Price   |   Syllabus

This is a 10-week advanced course for industry professionals who are serious about pursuing automation roles in the pharmaceutical industry.

Get a thorough understanding of how the CSV process fits into your software life cycle and the purpose of each validation deliverable.
Practice creating key validation deliverables such as GAMP 5 Software Categories and Life Cycle Phases, 21 CFR Part 11, Electronic Records and Electronic Signatures.
Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations.
Apply the FDA and international regulations and guidance regarding CSV on your current company projects.
Get the best practices for validation test execution, documentation, and error handling.
Use risk-based decision making in your software quality assurance procedures.

Online Learning Done Differently

or: Why this is an Online Course You’ll Actually Finish!

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.

Sample Videos

Watch this video Gamp 5 Software Categories

Watch this short video on operational activities

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GetReskilled Success Stories
Computer System Validation

Edel Harkins

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

Computer System Validation

Ronan Balfe

“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”

Computer System Validation

John Ryan

“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 content 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.”

Computer System Validation

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Computer System Validation

Ewa K.

“This course would give you chance to continue to seek an employment and at the same time you can study to improve your chances at the job market.”

Computer System Validation

James Fogarty

“This was fantastic opportunity for me to gain qualification in my own time. This would otherwise have been impossible due to cost and time due to child minding.”

Computer System Validation

Trish Kineen

“It has been a great course to re-familiarise myself with the area after such a long time away. I is also brilliant that you can study in your own time & at home (so you don’t have travel & child minding costs). I found the pace of the course good and really enjoyed it.”

Pharmaceutical Degree

Darren Deehan

“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”

Pharmaceutical Degree

David Masterson

“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”

Pharmaceutical Degree

Johan Rousseau

“Already told friends, and they are on the course. It is a good course to familiarize you with the Pharma Manufacturing Industry.”

Pharmaceutical Degree

Josephine Nelson

“I would recommend enrolling, the course is very interesting.”

Pharmaceutical Degree

Louise McManus

“Excellent course, well set out.”

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.

Price

Price

Price

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Please Note: There is an acute shortage of people with CSV Skills especially in the Republic of Ireland which has experienced a huge resurgence in construction in the last two years.

Syllabus

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 2 – 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.

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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.
This available worldwide and in certain US States. Contact us for details.

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