GMP Training For Beginners In The Pharmaceutical Industry. ONLINE Course for Individuals, Teams or Startups

Get a deep understanding of Good Manufacturing Practices (GMPs) really fast with this 4-Week Online Course. Learn how safe medicines and medical devices are made in a regulated GMP environment.

  • Get up to speed with the specialize concepts and terms used in pharma manufacturing

  • Extend your company or consultancy’s role into the pharmaceutical industry

  • 5 week online course – No needless travel

  • Application Deadline: Wednesday 3rd November
  • Study Online 10 hrs/week
  • 1 Module over 5 Weeks
  • Join 1120 Learners
GMP Manufacturing Training | Learn Good Manufacturing Practices
Apply NOW And Get a Deep Understanding of GMPs Really Fast

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GMP Training For Beginners In The Pharmaceutical Industry. ONLINE Course for Individuals, Teams or Startups

Get a deep understanding of Good Manufacturing Practices (GMPs) really fast with this 4-Week Online Course. Learn how safe medicines and medical devices are made in a regulated GMP environment.

Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems Course
  • Get up to speed with the specialize concepts and terms used in pharma manufacturing

  • Extend your company or consultancy’s role into the pharmaceutical industry

  • 5 week online course – No needless travel

  • Application Deadline: Wednesday 3rd November

  • Study Online 10 hrs/week
  • 1 Module over 5 Weeks
  • Join 1120 Learners

Our learners work for the world’s biggest pharma and medical device companies

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Pfizer Logo
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Our learners work for the world’s biggest pharma and medical device companies

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GSK Logo
Lonza Logo
Pfizer Logo
Roche Logo
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This Course is For You If;

  • You need to get a deep understanding of the GMPs really fast and familiarise yourself with the specialized concepts and terminology involved.

  • You have a business/sales/marketing background and want to get rapidly up to speed on Good Manufacturing Practices (GMPs).

  • You want end-of-week progress checks and follow-up by us to MAKE SURE you finish the course.

  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

Entry Requirements

Any of the following

  • Manufacturing
  • Project Manager, Project Engineer
  • Engineering
  • Pharmacist, Nurse
  • Automation/Control/Instrumentation Technician or Engineer
  • Quality Assurance or Quality Control Specialist
  • Laboratory Technician, Biochemist, Microbiologist
  • Maintenance Engineer or Technician
  • Pipe-fitter/Plumber, Pipe Welder, Electrician, etc
  • Logistics – Supply Chain Managers, Procurement
  • Military – Army, Navy, Air Force, etc
  • Business – MBA’s, Finance, Accountants, etc
  • Sales – Pharma Sales, Business Development, etc
  • Marketing
Apply NOW And Get a Deep Understanding of GMPs Really Fast

100% Privacy Guaranteed

Programme Highlights

  • You need to get a deep understanding of the GMPs really fast and familiarise yourself with the specialized concepts and terminology involved.
  • You have a business/sales/marketing background and want to get rapidly up to speed on Good Manufacturing Practices (GMPs).

  • You want end-of-week progress checks and follow-up by us to MAKE SURE you finish the course.

  • You don’t want to waste your time, money or training budget on hotel or travel junkets.

Entry Requirments

Any of the following

  • Manufacturing
  • Project Manager, Project Engineer
  • Engineering
  • Pharmacist, Nurse
  • Automation/Control/Instrumentation Technician or Engineer
  • Quality Assurance or Quality Control Specialist
  • Laboratory Technician, Biochemist, Microbiologist
  • Maintenance Engineer or Technician
  • Pipe-fitter/Plumber, Pipe Welder, Electrician, etc
  • Logistics – Supply Chain Managers, Procurement
  • Military – Army, Navy, Air Force, etc
  • Business – MBA’s, Finance, Accountants, etc
  • Sales – Pharma Sales, Business Development, etc
  • Marketing
Syllabus   Price   
Hear From People Who’ve Taken This Course
Manufacturing Safe Medicines

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.”

DPS Testimonials

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!”

DPS Education Testimonial

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.”

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.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the program.
How-does-Studying-Online-Work

Meet Your Online Classroom Support Team

When you learn at GetReskilled, you can always rely on an in-house team of experts to provide guidance and support, whenever you need it.

Lecturers

Safe Medicine Lecturers

Learn the systems, protocols, tools, vocabulary, and best practices from our Lecturer’s who have had decades of on the job experience.

Course Leaders

Safe Medicine Course Director

Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.

Course Coordinators

Safe Medicine Course Coordinators

Your CC’s are here to provide you with answers, tips, and are going to check your progress weekly to keep you on track and will reach out to you by email or even by phone if you fall behind!

Delivered by an Industry Expert

Dr.Joe Brady Lecturer

Dr. Joe Brady

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, DPS Education

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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.

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 Singapore, China, Ireland, The Netherlands, Belgium, France, and the USA.

Your 5-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
  • Topic-1 Finished Medicinal Products
    In this lesson, we learn about medical products and the various ways drug products are administered.
  • Topic-2 Focus on Patient Safety and Product Quality
    In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
  • Topic-3 ISO9001:2008
    This lesson is about the key requirements of a quality management system.
  • Topic -4 Product Quality and Current Good Manufacturing Practices [ cGMP ]
    In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP).
  • Topic -5 API Regulatory Guidelines
    In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
  • Topic-6 ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
    This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
  • Topic-7 Quality Systems Approach to Pharmaceutical cGMP Regulations-The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations, and evaluation activities.
  • Topic-8 FDAMedicalDeviceRules-CFR820
    In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
  • Topic -9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
    In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.
  • Topic-1 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
  • Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
    In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
  • Topic-3 PQ,OQ and IQ
    In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
  • Topic-4 Cleaning Validation
    This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.
  • Topic-5 Introduction to Quality Risk Management (QRM)
    In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
  • Topic -6 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
    In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
  • Topic -7 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
  • This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
  • Topic-8 Documenting the Quality Risk Management Process
    In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.
  • Topic-1 Batch Organic Chemical Synthesis
    In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
  • Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
    This lesson describes a conventional biotechnological process and introduces the following process sequences:

    • Stage-I – Upstream Processing
    • Stage-II – Fermentation / Bio-reaction
    • Stage-III – Downstream Processing
  • Topic -3 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic -4 Aseptic & Sterile Manufacturing
    In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.
  • Topic-1 Purified Water (PUW) Generation, Storage and Distribution
    2-6-1, 2-6-2, 2-6-3 In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • Topic -2 Clean Steam Generators – 2 videos
    3-5-1, 3-5-2 the objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • Topic -3 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
  • Topic -4 Engineering Aspects of Cleaning, and Cleaning Equipment
    This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
  • Topic-5 Chemistry Aspects of Cleaning
    This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
  • Topic -6 Steam Sterilization in Place
    In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • Topic-7 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between
    operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • Topic-8 Cleanroom Layout–2 videos
    4-3-1, 4-3-2, In these presentations, we take a high-level look at a common cleanroom configuration and discuss items
    such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
  • Topic -9 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination with safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
  • Topic -10 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic -11 Cleanroom Monitoring – Physical Tests
    In this lesson we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

  • The key requirements of a quality management system
  • The manufacturing responsibilities for quality systems
  • The cleaning validation sequence and how to determine cleanliness levels
  • The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
  • The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
  • The critical process parameters and quality attributes associated with the manufacture of tablets.
  • The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
  • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

You will receive an end of course certificate from GetReskilled 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 Manufacturing Safe Medicines & Medical Devices Course

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

GMP Manufacturing Training Certificate

Frequently Asked Questions

We release only one week’s worth of material at a time and then check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. There is a “Progress Bar “on your course which is helpful to you and us to know how you are doing.

You have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind. She’ll also be in touch weekly to let you know when new content is open for you.

Yes, this program is delivered fully online.

Each week of online content typically includes 6-10 topics.

Each topic includes:

  • A set of course notes – these provide additional depth to the video content.
  • Warm-up self-assessment question – to recap or activate any relevant prior learning.
  • A video – these are typically 5-10 minutes long and deliver 80% of the course content.
  • Post video self-assessment questions to check how well you can recall this new material from memory. If you can’t answer these questions, you should revisit that topic’s learning materials.
  • Any follow up assessments or assignments.

Most students report between 8-14 hours per week.

No you don’t. The online classroom is open 24 hours a day so you do not have to login at any particular time. We will give you a Username and Password on the day the program starts and this allows you 24 hours a day access.

Yes, you can speed up or slow down the rate of delivery to suit your requirements. The most important thing is communication between you and your course coordinator. If you are taking a break or are busy at work and do not have time to study you need to tell her or him. Similarly, if you want to study at a faster rate, then just email in good time and ask for more course content.

Yes, this course is relevant to both the pharmaceutical and medical device industries.

Price

One Person

Price For 1-Person

S$1,499

Application Deadline: Wednesday 3rd November 2021

Program Starts: 11th November

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Singapore
Call Geraldine: +(65) 6513 9500

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