gamp 5 training course

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

GAMP®5 can be frustrating but our ONLINE program will rapidly help you get your projects under control!
  • Go rapidly from total beginner to GAMP expert
  • Manage electronic data for FDA requirements
  • Complete online in 4 weeks – No Wasted Travel
  • Application Deadline: Wednesday 4th September
Price $1,299

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

GAMP®5 can be frustrating but our ONLINE program will rapidly help you get your projects under control!
gamp 5 training course. Learn good automated manufacturing practices
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DURATION
1 Module over 4 Weeks
Study Online 14 hrs/week 

LEVEL
Beginner – Intermediate
Join 837 Learners

APPLY BY
Wednesday 4th September
Class Starts: 12th September

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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.
Apply NOW And Get your GAMP®5 Projects Under Control!

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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.

About   Syllabus   Faq   Price   Apply

Entry Requirements

Any of the following:

  • You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment
  • Validation Engineer or Specialist
  • Automation/Control/Instrumentation Engineer
  • Quality Assurance or Quality Control Specialist
  • Maintenance Engineer or Technician
  • Laboratory Technician, Biochemist, Microbiologist

OR

  • Front/Backend Development or Enterprise Software.

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.

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.
Online courses can start off great, but staying motivated can be a challenge. So, we check your progress weekly to keep you on track and we’ll reach out to you by email or even by phone if you fall behind!
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.
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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 and Lecturer, Dublin Institute of Technology

Dr. Joe Brady is full-time practicing Validation Lead and 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.

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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.

Download Brochure
    • Drivers for GAMP®5
    • Life Cycle Phases of Computerized Systems
    • Computerized Systems in Regulated GxP Environments
    • GAMP®5 Software Categories
    • Operational Activities
    • Handover
    • Product and Process Understanding
    • End User Activities
  • 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
  • Organizational Change
  • Outsourced IS/IT Environment
  • IT Compliance
  • Development versus Implementation Life Cycle
  • Testing Documentation Structure & Verification Terminology
  • Scalable Validation Deliverables
  • Patch and Update Management
  • Operational Change and Configuration Management
  • Repair Activity
  • Periodic Review
  • Backup and Restore
  • Electronic Data Archiving Part
  • Typical Tasks Supporting Validation (B)
  • Security Management
  • Business Continuity Management
  • System Retirement Decommissioning and Disposal
  • Copies of Records
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

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

Join our Alumni who are working for:

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About   Syllabus   Faq   Price   Apply

Frequently Asked Questions

  • Is this course delivered online? Yes
  • I have never worked with GAMP before. Can I take this program? Yes, talk to our team
  • Can I pause the class if I get to busy at work or because of family commitments? Yes
  • Are all course materials available 24/7? Yes
  • Can I take this program at my own pace? Yes
  • Do I need to be online all the time? No you don't
  • I live in the UK/Europe/USA/Australia etc,. Can I still take this program? Yes
  • Can I have my employer pay for this? Yes
  • Can I spread the payments over a couple of months? Yes
  • Will I have my own personal course leader who follows up with me to make sure I get to the end of the course. Yes
  • Will I have access to the materials after the course is finished? Yes for 6 months.

Price

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

Price

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

Price

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

Application Deadline: Wednesday 4th September, 2019

Program Starts: 12th September

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Start Your Application

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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