Pharmaceutical Manufacturing

Fundamentals of Pharmaceutical Manufacturing

Learn How to Manufacture Safe Medicines in a Regulated Environment.
  • WSQ Accredited as (Apply Manufacturing Technologies in a
    Regulated Environment PI-PH-307E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: 5th June

Fundamentals of Pharmaceutical Manufacturing

Learn How to Manufacture Safe Medicines in a Regulated Environment.
  • WSQ Accredited as (Apply Manufacturing Technologies in a Regulated Environment PI-PH-307E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: 5th June
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing
Pharmaceutical Manufacturing

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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.

Learn How Medicine are Manufactured

Get a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied.

Apply Good Manufacturing Practices

Learn how to apply the cGMPs (current Good Manufacturing Practices) to manufacture safe medicines and medical devices.

Visualise Catastrophe

Use risk management tools to make good decisions in real life manufacturing situations.

API’s Vs BioPharmaceuticals

Understand the manufacture technologies for active pharmaceutical ingredients (API), biopharmaceuticals, and medical devices.

Build on this Initial Qualifications Further

Our Fundamentals of Pharmaceutical Manufacturing Course is the first step to getting a full BSc Degree and forms a potential pathway to join a rapidly expanding industry with huge job and career prospects.

Learn from Experts at Your Own Pace

The module is written and taught by our Lecturer – Dr. Brady – and you can complete it from the comfort of your own home in a 10-week period.

How does Studying Online Work?

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.
Hear From People Who’ve Taken This Course
Pharmaceutical Manufacturing

Renato Chato

“This course was very informative and could greatly enhance our knowledge and understanding on Pharma Manufacturing practices (GMP, GDP, etc.). The training experience was great and details were clear. Keep it up, guys!”

Pharmaceutical Manufacturing

Michael Cheong Yim Poh

“Once you tune in your mind set to studying online, it’s a great way to learn as you manage the pace yourself.”

Your Lecturer

Fundamentals of Pharmaceutical Manufacturing

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.

Download Brochure

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

Competency Based Assessment

The end of module assessment is a competency based open book exam where you will need to answer 8 essay style questions. Each essay will require about half a page to one page to answer. Your answer will be assessed as either competent or not yet competent. In addition, you will also have a 15 minute oral interview with our Subject Matter Experts.

Accredited under the WSQ Program

This module is accredited under the WSQ programme as (Apply Manufacturing Technologies in a Regulated Environment PI-PH-307E-1) subject to the following criteria. Passing a written and oral Exam on the materials.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete your competency based assessment and the end of module interview webinar to get your WSQ Certificate.

Add it to your resume, your LinkedIn profile or just get that well-earned raise you’ve been waiting for.

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Price

S$499/month

For 3 Months

S$1,347 in Advance

Save S$150

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Application Deadline: 5th June, 2019

Course Starts: 13th June

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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.