This Course is Right For You If;
- You want to learn how safe medicines and medical devices are made in a regulated GMP environment.
- You work in academia or a research laboratory and need to work with professionals in the pharmaceutical and med device manufacturing sector.
- You have to train your team on how safe medicines and medical devices are made in a regulated GMP environment as part of a GMP compliance, GMP refresher or GMP induction training programme.
Minimum Entry Requirements
- You have one of the following qualifications or work in any of the following:
- PhD, Masters, Degree or Diploma in Biochemistry, Microbiology, Molecular Biology, Laboratory/Science
- Management or Engineering Consultant
- Engineers or Technicians
- Quality Control or Quality Assurance
- Frontend/Backend/Full Stack or Enterprise Software Developer
- Logistics – Supply Chain Managers, Procurement
- Business – MBA’s, Finance, Accountants, etc
- Sales – Pharma Sales, Business Development, etc
- Packaging and labelling industry
- HR/Recruitment Specialists focused on life sciences, pharmaceutical, biotech or medical device industry
Note: If you want to retrain for an entry-level job in Pharmaceutical Manufacturing, check out our Conversion Course into Pharma Manufacturing.
If you want to retrain for a new career in the pharmaceutical manufacturing industry…
Choose from the following backgrounds to find the most suitable course.
No industry experience or a science or engineering qualification?
Check out our Conversion Course into Pharmaceutical ManufacturingLab/Science, Biochemistry, Chemistry, Microbiology or BioTech Background?
Check out our Conversion Course into Pharma for ScientistsQuality, Pharmacy or Food Science Background?
Check out our Conversion Course into Quality Roles in Pharma
Enroll in this course to learn…
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation
- Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
- FDA medical device rules – medical device regulations & guidelines
- GMPs vs ISO 9001:2015 – what’s the difference and why we use both
- Process validation and documentation – design and verification of manufacturing systems
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
- Supporting technologies – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
- Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application
- Working in a cleanroom environment – layout, classification, gowning and monitoring
- Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry
You’ll produce a number of deliverables throughout the course including…
- Complete the following 2 Quality Risk Management Tool workshops where you will learn to use worst-case scenario planning to figure out what could go wrong in the manufacturing process and come up with steps to mitigate those risks.
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
- Complete four-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
- Complete an end of module 4-5 page assignment to include:
- The key requirements of a quality management system
- The cleaning validation sequence and how to determine cleanliness levels
- The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
- The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
- The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
- The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment
And take the following skills and knowledge back to work…
- You’ll have a foundation in how safe medicines and medical devices are made in a regulated GMP environment.
- You’ll be able to participate in root cause analysis projects.
- You’ll have enough technical knowledge and understanding of the quality culture necessary to work in this environment.
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You’ll have the written communications skills to properly write reports and reference and cite source material in a manner that is consistent with the professional norms of this industry.
- You’ll be able to work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used in this sector.
Your 6-Week Class Schedule
Hear From People Who’ve Taken This Course
John Ryan
“The course content 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 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.”
Ronan Balfe
“I would have no hesitation in recommending these courses”
“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.”
Edel Harkins
“Highly recommended to anyone who has been out of the industry for a period of time”
“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!”
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.”
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.”
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 a Practicing Industry Expert
Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is a 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.
If you’re spending money on an education program, make sure you choose one you’ll finish!
With every GetReskilled ONLINE program;
- We use one centralized platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete a series of quizzes, tests, interactive activities, and projects. The course materials are available 24/7 and nothing requires you to be online at a specific day or time. i.e there are NO ZOOM classes and NO WEBINARS! Study anywhere, anytime, for example after the kids have gone to bed or on the weekend.
- Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
- We release only one week’s worth of material at a time and then MANUALLY check your activity logs at the end of every week to make sure that you are keeping up with your work.
- You’ll have a dedicated course leader who will email or telephone you if it looks like you’re starting to fall behind. They will work with you to develop a study plan to get you back on schedule and finish the course.
This all helps us to spot any potential issues early and helps you completely finish the program.
Show Off Your New Skills: Get a Certificate of Completion
Complete all assessments and the end of module written assignment to get certified in Good Manufacturing Practices (GMPs) and receive a Certificate of Completion.
Add details of your certificate to your CV/Resume or your LinkedIn profile.
16 Frequently Asked Questions
Yes, this program is delivered fully online.
- Click on the “Apply Now” button and fill out the application form.
- A member of our team will telephone you (within one or two working days) and chat through your application and make sure both you and the course are a good fit for each other. Please note: We may sometimes suggest a different course to the one you’ve applied for if it’s a better fit or a better way to get you to an employable level of knowledge sooner.
- After the telephone call, we will email you details of the telephone conversation covering:
- Course Overview
- Course Content
- Course Delivery & Certification
- Course Fees
- Registration Deadline, Start Dates and How to Register
- Link on the Online Registration Form
- You MUST complete the Online Registration Form to confirm your place on the course (It should take about 5 to 10 minutes to fill out the online registration form). Once completed, we will send an email acknowledgement confirming your registration.
- Our Course Director will telephone you just after the application deadline to arrange payment details.
- We will email your username, password and a link to your course on the course start date.
- Start your course!
Yes, that’s no problem.
Or you can pay by company credit card or bank transfer.
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.
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.
Most students report between 8-12 hours per week.
No – there are no specific times that you need to be online to take this course. There are NO ZOOM classes or live webinars! The online classroom is open 24-hours a day, you do not have to login at any particular time. The day the course starts, we will give you a username and password and this allows you 24/7 access to your course.
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, you can study all the way to a Degree.
STEP 1, this program is a stepping-stone to our follow-on specialisation, Certificate in eBioPharmaChem. Take this Certificate to get a level 7 university qualification from Technological University Dublin, Ireland to get a more interesting job with a higher salary
STEP 2, then take our Certificate in Validation to move into a validation role.
STEP 3, Finally, if you have completed our Certificate in eBioPharmaChem and Certificate in Validation which are standalone programs, you are already halfway to a level 7 Degree. Take 6 more modules to get a degree in Degree in Manufacture of Medicinal Products (DT 291)
Yes, you can. You don’t need to have a degree or diploma to take this course.
Yes, our programs are recognised by all the world’s leading pharmaceutical and medical device manufactures. In addition, we can provide an education verification check (assuming you have successfully completed this program) to meet any employer or other third parties requests.