You will write a 3,000-word technical report about a new aseptic manufacturing facility
As part of your End of Module Assignment, you will write a 3,000-word technical report to present to senior management about the air, water and steam systems that underpin and support aseptic/sterile processing and cleanroom manufacturing work in a new aseptic pharmaceutical manufacturing plant. The report should cover the 5 key sections:
- Production Logistics
- Process Flow
- Site Master Plan
- Cleanroom Layout
- Utility Support Systems
Your report will help management make critical decisions about the plant design.
Our chemical engineers will review your report and give you written feedback.
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
- You are a chemical / process / project / mechanical, etc engineer or an MSAT scientist.
- You are a maintenance/facilities engineer or technician and are responsible for making sure the cleanroom and utilities are sterile and safe.
- Quality control or quality assurance
- Tech transfer
- Upstream/downstream manufacturing
- You are responsible for planning the personnel and material flows and pressure profiles to prevent cross-contamination in sterile manufacturing environments.
Enroll in this course to learn…
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing, and aseptic & sterile manufacturing.
- Purified water generation – storage and distribution that underpin aseptic/sterile processing.
- Clean steam – water for injection, storage, and distribution that underpin aseptic/sterile processing.
- Instrumentation process control design – for the generation and distribution of clean utility systems.
- Cleanroom layout design – layout and classification along with the environmental controls pressure profiles.
- Aseptic processing – lyophilization and how vials are filled in an aseptic environment.
- Quality systems – for cleanrooms for both EMA and FDA guidance on aseptic processing.
You’ll produce a number of deliverables throughout the program including…
- Complete 10-question booklets (one for every week’s worth of study content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
End of Module Assignment
- Complete an end of module assignment to include the following:
- Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
- Describe process support and utility systems encountered on a typical biopharmaceutical facility.
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
- Describe the similarities and differences between pharmacopoeia grade purified water (PUW) and water for injection (WFI).
And take the following skills and knowledge back to work…
- You’ll have a strong foundation in how safe medicines and medical devices are made in a GMP regulated manufacturing environment.
- You’ll understand the air, clean water, and steam systems that underpin aseptic/sterile processing.
- You’ll understand cleanroom layout design, layout and classification, and the environmental controls pressure profiles.
- You’ll have the technical knowledge and understanding of the quality culture necessary to work in this environment.
Course Price
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!”
Your 13-Week Class Schedule
This module was developed in consultation with the pharma industry including Pfizer and MSD.
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.
Course Price
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.

Earn a Certificate of Award in the Principles of Pharmaceutical Facility Design
Earn by successfully completing a 3,000-word report to give senior management the information they need to make informed decisions about building a new aseptic manufacturing facility.
dd details of your certificates to your CV/Resume or your LinkedIn profile.

Price
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
Price
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
Price
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
Application Deadline: Wednesday 19th March
Program Starts: 26th March
Start Your Application
Contact Details For This Course
Geraldine Creaner
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