This Course is Right For You If;
- Need to apply these concepts at work in a daily basis
- You have direct experience working in an FDA regulated environment
- You need an Advanced Course that goes deep into this subject
- You don’t want to waste time or money on hotel or travel fees.
This course is probably not for you, if
- You have never worked in the pharmaceutical or medical device manufacturing industry.
What Does the Online Classroom Look Like?
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.
Hear From People Who’ve Taken This Course
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!”
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.”
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.”
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.”
Your Lecturer
Dr. 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.
Your 10-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.
Week 1 – Controlling Air Quality and Clean Utilities Manufacturing Logistics Calculations
- Process Flow Diagram (PFD)
- Controlling Air Quality
- Heating, Ventilation, and Air Conditioning (HVAC) Systems
- Biopharmaceutical Unit Operations – Drug Substance
- Biopharmaceutical Unit Operations – Drug Product
- Pharmacopeia Grade Waters
- Process Support and Utilities
- Introduction to ISO 9001:2008
- Typical GMP list for drug substance
- Operational Activities
- GMP for Personnel
- Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Model
- Maintenance: Good and Best Practices
Week 2 – Purified Water Generation and Distribution
- Project Lifecycle for New and Modified Facilities
- IPlant Layout
- Layout For Bulk Process Building
- Site Layout
- IZoned Air Conditioning System
- Isolator technology
- IIsolators and RABs
- Cell Breakage
- IPurified Water
- Purified Water Generation
- IPurified Water Storage and Distribution
- Clean Room and Clean Air Device Monitoring
- Good Engineering Practices Procedures
- GMPs for Buildings and Facilities
- Maintenance Program
Week 3 – Clean Steam and Sterilization
- Conceptual Design – Part-I
- HAVC Requirements for Non Sterile API Manufacturi
- Plant Automation
- Plant Steam
- Clean Steam Generators
- Clean Steam Generators 2
- Steam Sterilization-In-Place
- GMPs for Process Equipment
- Quality Systems Approach to Pharmaceutical cGMP Regulations – Resources
Week 4 – Controlling Material and Personnel flows
- Conceptual Design – Part-II
- Air Flow Patterns
- Air Flow Patterns Laminar Flow Systems
- Cleanroom Layout General Introduction
- Cleanroom Layout HVAC Containment (non-sterile API manufacturing)
- Filter Ratings – European Standards
- Filter Ratings – MERV Rating
- Logic Gates Functions, and Programmable Logic Controller (PLC)
- Water for Injection (WFI) Storage and Distribution
- Principles of Good Engineering Practices (GEP)
- Quality Systems Approach to Pharmaceutical cGMP Regulations – Manufacturing
- Maintenance Work Execution
Week 5 – Aseptic Processing and Vial Filling
- Site Master Planning – Part-I
- Classification of Clean Areas – Vial Filling
- Classification of Clean Areas – Cleanroom HVAC Configurations
- Classification of Clean Areas – AHU
- Classification of Clean Areas – Particles
- Classification of Clean Areas – CFU
- Area Classification Protection
- Compressed Air, and Pneumatics
- Aseptic Filling – Sterile Medicinal Containers
- Aseptic Filling – Vial Inspection
- Aseptic Filling – Vial Washing
- Aseptic Filling – Vial Depyrogenation
- Aseptic Filling – Vial Filling
- Cleanroom Gowning
- Aseptic Processing – Automated Loading System
- Aseptic Processing – Manual Loading System
- Aseptic Processing – Automated Barrier Systems
- Cleanroom Monitoring – Physical Tests
- Quality System – Evaluation Activities
- Maintenance Management
Week 6 – Controlling Cleanrooms and Automation
- Site Master Planning – Part-II
- Open versus Closed Processing
- Facility Layout Concept
- Blow/fill/seal technology
- PLC Programming
- PLC Program Case Studies
- Cleanroom Monitoring – Microbiological Tests
- Cleanroom Monitoring – Cleanrooms Cleaning Procedures
- Terminally sterilised products
- EU Guidelines on Clean Room Aseptic preparation
Week 7 – Quality Systems for Cleanrooms
- HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
- Batch Process Control
- Nitrogen Supply and Distribution
- Environmental Monitoring Program
- ICH Q10 – Pharmaceutical Quality System
- FDA Guidance on Aseptic Processing
Week 8 – Construction Lifecycle for New and Modified Facilities
- Construction Lifecycle – New and Modified Facilities
- Construction Lifecycle – Test Packs
- Construction Lifecycle – Modular and Sustainability
- Software Functional Block Diagram (FBD)
- ASTM E 250
Complete the Following Activities & Workshops
You will produce a number of deliverables during the course including:
- Calculating Mass Balances and Equipment Sizing
- Designing a Clean Utility generation and distribution system
- Defining the cleanroom layout for safe material and personnel flows
- Describing the Quality System necessary for manufacturing safe medicines
Complete an End of Module Assignment
Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.
Certified by GetReskilled
You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;
- Passing a written or oral Exam on the materials.
- The submission of all assessments and the end of module assignment.
Show Off Your New Skills: Get a Certificate of Completion
Once the course is over, complete a written assignment to get certified in Principles of Pharmaceutical Facility Design
Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.
Price
Price for 1-Person
$999/month
for 3 months
Price for 1-Person
$2,499 in Advance
Save $498 Dollars
Enrol a Team of 5 People
$9,999
Save $2,496 Dollars
Please Note: You must be a full time resident in Ireland to avail of these prices.
Price for 1-Person
€599/month
for 3 months
Price for 1-Person
€1,495 in Advance
Save €302 Euro
Enrol a Team of 5 People
€5,999
Save €1,476 Euro
Price for 1-Person
€899/month
for 3 months
Price for 1-Person
€2,299 in Advance
Save €398 Euro
Enrol a Team of 5 People
€8,750
Save €2,375 Euro
Price for 1-Person
£799/month
for 3 months
Price for 1-Person
£1,999 in Advance
Save £398
Enrol a Team of 5 People
£7,499
Save £2,496
Try Us Risk FREE for 7 Days 100% Money Back Guarantee.
Price
Please Note: You must be a full time resident in Ireland to avail of these prices.
Price for 1-Person
€599/month
for 3 months
Price for 1-Person
€1,495 in Advance
Save €302 Euro
Enrol a Team of 5 People
€5,999
Save €1,476 Euro
Price for 1-Person
€899/month
for 3 months
Price for 1-Person
€2,299 in Advance
Save €398 Euro
Enrol a Team of 5 People
€8,750
Save €2,375 Euro
Price for 1-Person
$999/month
for 3 months
Price for 1-Person
$2,499 in Advance
Save $498 Dollars
Enrol a Team of 5 People
$9,999
Save $2,496 Dollars
Price for 1-Person
£799/month
for 3 months
Price for 1-Person
£1,999 in Advance
Save £398
Enrol a Team of 5 People
£7,499
Save £2,496
Try Us Risk FREE for 7 Days 100% Money Back Guarantee.