Pharmaceutical Facility Design

Pharmaceutical Facility Design

Learn about clean utilities, cleanrooms & quality mgmt systems for manufacturing medicines.
  • WSQ Accredited as (Illustrate a Lifecycle Plan for a
    Manufacturing Facility PI-PH-311E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: Wednesday 4th September

Pharmaceutical Facility Design

Learn about clean utilities, cleanrooms & quality mgmt systems for manufacturing medicines.
  • WSQ Accredited as (Illustrate a Lifecycle Plan for a
    Manufacturing Facility PI-PH-311E-1)
  • Enjoy flexible Online Delivery
  • Get an Industry Recognised Qualification
  • Application Deadline: Wednesday 4th September
Pharmaceutical Facility Design
Pharmaceutical Facility Design
Pharmaceutical Facility Design
Pharmaceutical Facility Design
Pharmaceutical Facility Design
Pharmaceutical Facility Design

Intermediate

Join 1,923 Learners

Online, 10 weeks

16 hrs / week

What this Course will Teach You:

An injection bypasses all of your body’s natural defenses. How do you make sure that the cleanroom used in the manufacture of sterile medicines are absolutely safe? How do you make sure the water used in these injections is pure? In this practical course, you will learn all this and more.

Air and Water Systems

Learn about the air and water systems used for pharmaceutical manufacturing that underpin aseptic/sterile processing and the quality systems used in this highly regulated environment.

Cleanroom Layout

Design the cleanroom layout and the environmental controls pressure profiles necessary to meet the materials and personnel flows in a manufacturing facility.

Instrumentation and Process Control Design

Design the piping, instrumentation and process control design for the generation and distribution of clean utility systems.

Calculate the Mass Balance

Calculate the mass balance for a process. Conduct site master planning for a new or modified manufacturing facility.

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.

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

Pharmaceutical Facility Design

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 – 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

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 by the WDA under the WSQ Program

When this module is taken under the WSQ programme as (Illustrate a Lifecycle Plan for a Manufacturing Facility PI-PH-311E-1) it is accredited by the WDA 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$1,299/month

For 3 Months

S$3,499 in Advance

Save S$150

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

Application Deadline: Wednesday 4th September, 2019

Course Starts: 12th September

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Singapore
Call Geraldine: +(65) 6513 9500

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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.