DURATION
1 Module over 10 Weeks
Study Online 14 hrs/week
APPLY BY
September 8th
Class Starts: September 13th
LEVEL
For New Employees
Join 3124 Learners
This Course is Right For You If;
- You want to get a basic understand of how pharmaceutical manufacturing works and familiarise yourself with the specialize concepts and terminology involved.
- You are looking for a stepping stone to our follow-on specialization in eValidation or eBioPharmaChem.
This course is probably not for you, if
- You already have a background in manufacturing, food production, science or engineering.
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.”
Ewa K.
“This course would give you chance to continue to seek an employment and at the same time you can study to improve your chances at the job market.”
James Fogarty
“This was fantastic opportunity for me to gain qualification in my own time. This would otherwise have been impossible due to cost and time due to child minding.”
Trish Kineen
“It has been a great course to re-familiarise myself with the area after such a long time away. I is also brilliant that you can study in your own time & at home (so you don’t have travel & child minding costs). I found the pace of the course good and really enjoyed it.”
Darren Deehan
“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”
David Masterson
“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”
Johan Rousseau
“Already told friends, and they are on the course. It is a good course to familiarize you with the Pharma Manufacturing Industry.”
Josephine Nelson
“I would recommend enrolling, the course is very interesting.”
Louise McManus
“Excellent course, well set out.”
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 Ph.D. 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 – Manufacturing Safe Medicines
- Finished Medicinal Products
- Introduction to Quality Risk Management (QRM)
- Risk Management Tools – Fault Tree Analysis (FTA)
- Clinical Trials
- Focus on Patient Safety and Product Quality
- Process Validation
Week 2 – GMP’s and Quality Management Systems
- ISPE Baseline Guide 5 – Commissioning & Qualification Practices
- Risk Management Tools – Cause and Effect Diagram
- ISO 9001:2008 ‘Quality Management Systems – Requirements’
- Good Engineering Practices (GEP)
- ASTM E 2500– 07 Standard Guide for Specification, Design, and Verification of Equipment
Week 3 – Good Automated Manufacturing Practices (GAMP)
- GAMP5 – Software Categories & Scalable Validation Deliverables
- GAMP5 – Operation Activities
- Risk Management Tools – Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC)
- GAMP5 – Risk-Based Decision Making
- Product Quality and Current Good Manufacturing Practices (cGMP)
Week 4 – API Manufacturing Technologies
- Chemical Reactions
- Separation Technologies
- Batch Organic Chemical Synthesis
- Risk Management Tools – Preliminary Hazard Analysis (PHA)
- Multi-Stage Sequence API Synthesis
- Regulatory guidelines for synthetic API Manufacturing
- Relationship Between BPC and API
Week 5 – Biopharmaceutical Manufacturing Technologies
- Biopharmaceuticals Manufacturing, Upstream, Fermentation
- Cellular Protein Synthesis
- Risk Management Tools – Hazard Operability Analysis (HAZOP) –TC
- Biopharmaceuticals Manufacturing – Downstream Processing – Column Chromatography
- Biopharmaceuticals Manufacturing: Special Considerations
Week 6 – Cleaning Validation
- Engineering Aspects of Cleaning, and Cleaning Equipment
- Chemistry Aspects of Cleaning
- Risk Management Tools – Event Tree Analysis (ETA)
- Cleaning Validation
- ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
Week 7 – Medical Devices and Sterile Manufacturing
- Tablet Manufacturing
- Vial Filling & Freeze Drying
- FDA Medical Device Rules
- Risk Management Tools – Hazard Analysis and Critical Control Points (HACCP)
- Medical Devices – EU Classification
- Aseptic & Sterile Manufacturing
- Medical Device Regulations and Guidelines
Week 8 – PQ OQ IQ
- PQ, OQ IQ
- Documenting the Quality Risk Management Process
- Product Realization & Pharmaceutical Development
Complete an End of Module Assignment
Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.
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 The Fundamentals of Pharmaceutical Manufacturing Technologies
Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.
Frequently Asked Questions
- Is this course delivered online? Yes
- I have never worked in the Pharmaceutical or Medical Manufacturing Industry before. Can I take this program? Yes, talk to our team
- Can I pause the class if I get to busy at work or because of family commitments? Yes
- Are all course materials available 24/7? Yes
- Can I take this program at my own pace? Yes
- Do I need to be online all the time? No you don't
- I live in the UK/Europe/USA/Australia etc,. Can I still take this program? Yes
- Can I have my employer pay for this? Yes
- Can I spread the payments over a couple of months? Yes
- Will I have my own personal course coordinator who follows up with me to make sure I get to the end of the course. Yes
- Will I have access to the materials after the course is finished? Yes for 6 months.
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
$9,996
Save $2,499
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
€5,980
Save €1,495
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
€9,196
Save €2,299
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
£7,996
Save £1,999
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
€5,980
Save €1,495
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
€9,196
Save €2,299
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
$9,996
Save $2,499
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
£7,996
Save £1,999
Try Us Risk-FREE for 7 Days 100% Money Back Guarantee.
Price
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
€9,196
Save €2,299
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
€5,980
Save €1,495
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
$9,996
Save $2,499
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
£7,996
Save £1,999
Try Us Risk-FREE for 7 Days 100% Money Back Guarantee.
Price
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
£7,996
Save £1,999
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
€9,196
Save €2,299
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
€5,980
Save €1,495
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
$9,996
Save $2,499
Try Us Risk-FREE for 7 Days 100% Money Back Guarantee.
Start Your Application
Click below to start your application.
Talk To Our Team
USA/World
Call Geraldine: +1 (617) 901 9268
Ireland
Call Sinead: +353 (0)21 2409016