GAMP 5 – Good Automated Manufacturing Practice

Learn the best practice guidelines of GAMP 5 for a computerized system

  • Manage electronic data for FDA requirements
  • Drivers for GAMP 5 and life cycle phases
  • Complete course from anywhere online in 4 weeks

Intermediate

Join 837 Students Worldwide

Online, 4 weeks, 14 hrs / week

Price   |   Syllabus

Learn the Best Practice Guidelines of GAMP 5

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 Video

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.
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GetReskilled Success Stories
GAMP 5

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!”

GAMP 5

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.”

GAMP 5

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.”

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.”

Lecturer

Joe Brady
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.

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Price

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Price

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Syllabus

Week 1 – Software Categories, Life Cycle Phases, and Operational Activities

  • 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

Week 2 – Science Based Quality Risk Management, Validation Planning, and Categorization of Laboratory Computerized Systems

  • 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 3 – Specification and Verification, Scalable Validation Deliverables and Configuration Management

  • 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

Week 4 – 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

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.

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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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