Fundamentals of Pharmaceutical Manufacturing

Learn How to Manufacture Safe Medicines in a Regulated Environment

  • Learn how medicines are made using GMPs
  • Use risk management tools to make better decisions
  • Online, Part-time. Study while you work

Beginner

Join 3,124 Students Worldwide

Online, 10 weeks, 14 hrs / week

Price   |   Syllabus

Learn How to Manufacture Safe Medicines in a Regulated Environment

How do you make the safe and effective medicines? What do NASA and the pharmaceutical industry have in common?
Learn the answers and more in this module.

Get a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied.
Learn how to apply the cGMPs (current Good Manufacturing Practices) to manufacture safe medicines and medical devices.
Use risk management tools to make good decisions in real life manufacturing situations.
Understand the manufacture technologies for active pharmaceutical ingredients (API), biopharmaceuticals, and medical devices.
Finished Medicinal Products Biopharmaceutical Manufacturing (Up & Downstream)
API Manufacturing
Medical Devices
Sterile Manufacturing
cGMPs and Quality Management Systems
ISPE Baseline Guide 5 / ASTM E2500
IQ/OQ/PQ and Process Validation
Continuous Improvement and CAPAs (ICH Q10)
GAMP® 5
Quality Risk Management Techniques and Tools
(ICH Q9)
Cleaning Validation

Watch Video

Watch a sample video from the course on IQ/OQ/PQ and Process Validation

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.
Join our alumni who are working for
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Join our alumni who are working for
GetReskilled Success Stories
Pharmaceutical Degree

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!”

Pharmaceutical Degree

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.”

Pharmaceutical Degree

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.”

Computer System Validation

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.”

Computer System Validation

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.”

Computer System Validation

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.”

Computer System Validation

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.”

Pharmaceutical Degree

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.”

Pharmaceutical Degree

David Masterson

“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”

Pharmaceutical Degree

Johan Rousseau

“Already told friends, and they are on the course. It is a good course to familiarize you with the Pharma Manufacturing Industry.”

Pharmaceutical Degree

Josephine Nelson

“I would recommend enrolling, the course is very interesting.”

Pharmaceutical Degree

Louise McManus

“Excellent course, well set out.”

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.

Price

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Price

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Price

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Syllabus

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.

Got More Questions?

My Name*

My Email*

My Message*

 

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.

View all FAQ’s