How do you replace paper with electronic data and make sure the system is completely transparent, robust and tamperproof? 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.
Learn how to manage your electronic data to ensure that it meets the FDA requirements for manufacturing safe medicines and medical devices.
Learn the fundamentals of computer system hardware and software and how to manage your electronic data so as to be in compliance with GAMP 5.
Validate your automated equipment and processes to ensure that they meet FDA requirements for the manufacture of safe medicines and medical devices.
Learn how to apply GAMP 5 as part of continuous improvement and operational excellence initiatives
Drivers for GAMP 5 and Life Cycle Phases Computerized Systems in ‘GXP’ Environments Science based Quality Risk Management Supplier Activities and Validation Planning IT Compliance -Key Concepts Development Versus Implementation Life Cycle Specification and Verification Patch and Update Management
Operational Change and Configuration Management Controls to Maintain Electronic Record Integrity Typical Tasks Supporting Validation Security Management Business Continuity Management Relationship between System Backup Archival Disaster Recovery System Retirement Decommissioning
Watch a sample video from the course on the “Life Cycle Phases of Computerised Systems”
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.
Join our alumni who are working for
Join our alumni who are working for
GetReskilled Success Stories
“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!”
“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.”
“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.”
“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.”
“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.”
“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.”
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.
Week 4 – Electronic Data Archiving, Business Continuity Management, and System backup, Archival, and Disaster Recovery
Electronic Data Archiving Part
Typical Tasks Supporting Validation (B)
Business Continuity Management
System Retirement Decommissioning and Disposal
Copies of Records
Complete the Following Activities & Workshops
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
Complete an End of Module Assignment
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.
Certified by GetReskilled
You will receive an end of course certificate from GetReskilled.
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.