GAMP 5 Training Course – Retrain ONLINE for GAMP®5 Projects

GAMP®5 can be frustrating but our ONLINE program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework.
  • Learn the process used to test, validate and formally document that a regulated GxP computerized system application does exactly what it is designed to do.

  • Go rapidly from beginner to GAMP expert.

  • Extend you or your team’s role into GAMP projects. Charge higher hourly rates.

  • Application Deadline: Wednesday 17th April

  • Study Online part-time
  • 12hrs/week for 4 weeks or choose a faster/slower schedule
  • Join 1010 learners

Note: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course

End-of-week progress checks and follow-up by us to MAKE SURE you or your team finish the course.

Contact Details For This Course

Geraldine Creaner

GAMP 5 Training Course – Retrain ONLINE for GAMP®5 Projects

GAMP®5 can be frustrating but our ONLINE program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework.
gamp 5 training course. Learn good automated manufacturing practices
  • Learn the process used to test, validate and formally document that a regulated GxP computerized system application does exactly what it is designed to do.

  • Go rapidly from beginner to GAMP expert.

  • Extend you or your team’s role into GAMP projects. Charge higher hourly rates.

  • Application Deadline: Wednesday 17th April

Note: You’ll get a dedicated course leader who’ll work with you to develop a weekly study schedule, then check your progress every Friday and follow up with you to help you finish the course.

  • Study Online part-time
  • 12hrs/week for 4 weeks or choose a faster/slower schedule
  • Join 1010 learners

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

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Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

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Boston Scientific Logo

Medtronic Logo

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Why Take This Course?

How do you replace paper with electronic data and make sure the system is completely transparent, robust and tamper proof? And how do you store those electronic data records so that they stand the test of time? In this practical course, you will learn all this and more.

This Course is Right For You If;

  • The CSV Engineer just left and you’ve been handed all their GAMP®5 responsibilities.

  • You work in Validation or Automation and want to extend your role to GAMP®5.
  • You have a hectic work and home schedule and can’t afford 3, 4 or 5 days out of the office.

  • You want end-of-week progress checks and follow-up by us to MAKE SURE you finish the course.
  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

Take the following skills and knowledge back to work:

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Contact Details For This Course

Geraldine Creaner

This Course is Right For You If;

  • The CSV Engineer just left and you’ve been handed all their GAMP®5 responsibilities.

  • You work in Validation or Automation and want to extend your role to GAMP®5.

  • You want end-of-week progress checks and follow-up by us to MAKE SURE you finish the course.

  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

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

Pfizer Logo

AstraZenega Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

Entry Requirements

This program is highly specialized so you MUST have a solid understanding of GMP rules, regulations and guidelines.

AND you are any of the following…

  • Validation Engineer/Specialist or Senior Validation Manager
  • PhD, Masters or Degree in Biochemistry, Microbiology, Molecular Biology, Lab/Science, etc
  • Automation, Control/Instrumentation, Process, Manufacturing, etc Engineer or Technician
  • Quality Assurance or Quality Control Technician or Specialist
  • Metrology, Maintenance Engineer, Technician or Specialist
  • Front/Backend Developer
  • Not sure if you meet the minimum requirements? Contact us.

Add On Program: If you don’t have experience working in a GMP manufacturing environment, you need to start with our 4-Week GMP Training For Beginners For The Pharmaceutical Industry.

If you want to learn GAMP®5 and 21 CFR Part 11 together, then take our 10-week online program on Computer System Validation

Your 4-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.

  • 1.1 Drivers for GAMP®5
    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 GAMP®5 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 Supplier Activities
    This lesson explains the responsibilities of the supplier when it comes to supporting the lifecycle activities for a computerized system.
  • 2.2 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.
  • 2.3 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.
  • 2.4 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.
  • 2.5 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.
  • 2.6 Efficiency Improvements (Continuous Improvements)
    In this lesson, we look at suggestions on ways to improve efficiencies throughout the lifecycle of a computerized system.
  • 2.7 Categorization of Laboratory Computerized Systems
    This lesson explains the GAMP® system for categorizing Laboratory Computerized Systems.
  • 3.1 Organizational Change – Impact During Project Lifecycle
    This lesson looks at various ways to manage projects during episodes of major organizational changes.
  • 3.2 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.
  • 3.3 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.
  • 3.4 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.
  • 3.5 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.
  • 3.6 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.
  • 3.7 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.
  • 3.8 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.
  • 3.9 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.
  • 5.10 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.
  • 3.11 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.
  • 4.1 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.
  • 4.2 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.
  • 4.3 Security Management
    In this lesson, we define the controls required for securing a computerized system in an operational environment.
  • 4.4 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.
  • 4.5 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.
  • 4.6 Copies of Records
    This lesson considers methods on how to preserve the content and meaning of an electronic record when making a copy.
You will produce a number of deliverables during the course including:

  • Identify where you would use risk based decision making  throughout the lifecyle of a computerized system
  • Schematically represent typical architectural components of a computerized system
For a computerized system that has GxP applicability, prepare a report, with diagrams and schematics, describing typical business and GMP functions and describe a suitable approach to the four lifecycle phases: Concept; Project; Operation and Retirement.
You will receive an end of course certificate from GetReskilled.
ISPE owns the GAMP® trademark https://www.ispe.org

What Does the Online Classroom Look Like?

How-does-Studying-Online-Work

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 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 GAMP®5 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 GAMP®5 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.”

Pharmaceutical Facility Design

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.”

Pharmaceutical Facility Design

Anne Reilly

“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”

Pharmaceutical Facility Design

Louise McManus

“Excellent course, well set out.”

Andy Wnuk, MSc (Eng) MIEI

“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”

David O’Shea, March 2012

“I found this course very beneficial and I am delighted that, even at early stages in the course, it has already provided me with the opportunity to secure a position within the pharmaceutical industry.”

Denis Hegarty, May 2012

“I found the course was run very professionally, The course notes and videos supplied were excellent, the notes tied in very efficiently and accurately with the videos. Dr Joe Brady’s presentation on the videos and his expertise and help at the webinars was outstanding. I found it very easy to continue studying even though I found employment two months into the course. I would highly recommend this course to anyone hoping to further their education in this field.”

Tan Sear Enyu, Venture Corporation Limited, SA

“The lecturers have vast knowledge to share and are technical specialists within the Life Sciences Industry…there was a lot of encouragement and team exchange of experience to bring in for class work and assignment participation.”

Delivered by an Industry Expert

Dr. Joe Brady

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

Dr. Joe Brady is 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 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 twenty years of project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

Show Off Your New Skills: Get a GAMP 5 Certificate of Completion

Once the course is over, complete a written assignment to get certified in GAMP®5 – Good Automated Manufacturing Practice

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

gamp 5 certification

Frequently Asked Questions

The GAMP®5 Training program is delivered online over 4 weeks and only focuses on GAMP®5 approach to data integrity.

Our Computer System Validation program covers both GAMP®5 and 21 CFR Part 11 and is delivered online over 10-weeks.

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.

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.

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.

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, a number of our students have their employers pay for this program.

Price

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Price

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

Price

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Application Deadline: Wednesday 17th April

Program Starts: 25th April

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Click below to start your application for our GAMP®5 course.

Talk To Our Team

USA/World
Call Geraldine: +1 (617) 901 9268

Ireland
Call Sinead: +353 (0)21 2409016

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