Programme Highlights
Commissioning and qualification of equipment and systems is a critical process in making sure safe medicines are being manufactured. In addition, this module is one of the first steps you’d take to specialise in Validation – where there is currently an acute shortage trained validation professionals.
Perfect For People with Engineering, Science, Manufacturing, IT or Quality Background
Perfect for anyone with a manufacturing, science, engineering, quality, maintenance, aviation/semiconductor, food production, construction, military or logistics background.
Build Your Qualifications Further after graduating
Our Commissioning and Qualification Course forms a potential pathway to become a full Validation Professional with subsequent courses. Validation is currently an area where there is huge demand for professionals.
Portfolio Building – Give Yourself a Competitive Edge
By the end of the course you will be able to write an IQ, OQ Protocol. Compile a portfolio based on your final assignment to demonstrate to future employers your knowledge in the field.
Learn from Experts at Your Own Pace
The module is written and taught by our Validation expert – Dr. Brady – and you can complete it from the comfort of your own home in a 10-week period.
How does Studying Online Work?
Hear From People Who’ve Taken This Course
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!”
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
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.
Week 1 – Interpreting P&ID’s
- Design Documents Required for the Generation of Installation and Functional Tests
- User specification for a Reactor
- Equipment Configuration and Process Sequence for a Reactor
- Generation of Piping and Instrumentation Diagrams (P&ID)
- URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
- Equipment List
- Instrument List
- Inline Components List
Week 2 – System Impact Assessment & Traceability Matrix
- Protocol Content Part 1: Objective, System Description and Scope
- System Impact Assessment
- cGMP Testing Principles
- Valves
- Piping Line List
- Testing Traceability Matrix for Equipment Systems
Week 3 – Installation Tests & Equipment Verification
- Protocol Content – Part 2: Responsibilities and Installation Testing
- Minimum Elements of a Test Script
- Good Documentation and Records Management
- Component Level Impact Assessment – Part-1 Product Contact Components
- Installation Test P&ID Walk-Down
- Installation Test and Equipment Verification
- Pumps
Week 4 – Piping Isometrics & Checksheets
- Piping Components
- Piping Isometrics 2D P&ID and 3D CAD Images
- Piping Isometrics and 3D CAD
- Piping Material Traceability
- Piping Tests
- Heat Exchangers
- Instrumentation Identification
- Installation Test Piping Verification GMP-Checklist
Week 5 – Instrument Loops & Checksheets
- Process Control
- P&ID Instrument Identification
- Input Output (1/O) List
- Process Control Hardware Panels
- Loop Signal Verification
- Installation Test Instrument Verification
- Proportional-Integral-Derivative Controller (PID Controller)
Week 6 – URS & Functional Testing
- Protocol Content – Part-3 Operational/Functional Testing
- Component Level Impact Assessment – Part-2
- Operational Testing Primary Functions GMP Checksheet
- Testing Traceability Matrix for Equipment System Second Pass
- User Requirement Specifications (URS)
Week 7 – Assembling the Validation Protocol
- Protocol Content – Part – 4: General Attachments
- Protocol General Attachments
- General Contents of a Validation Master Plan
- Protocol Deviation Procedure
- Change Control Procedure
- Protocol Testing Template
- Testing Traceability Matrix for Equipment System
Week 8 – Validation Protocol Final Review
- Conclude List of Installation Tests
- Conclude List of Functional Tests
- Final Protocol Template Review
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.
Complete the Following Activities and Workshops
You will become familiar with a range of documents used in projects including piping and instrumentation diagrams (P&ID), equipment specifications, instrument specifications, line lists, piping isometrics, 3D layouts, electrical and hardware control – panel diagrams, and wiring and loop diagrams. These design documents are used to generate IQ OQ PQ commissioning and qualification protocols.
You will also become familiar with:
- User Requirement Specifications (URS)
- cGMP impact-assessments
- cGMP design reviews
- Design Qualification (DQ) reports
- Specification and testing traceability matrices
- Typical testing IQ OQ PQ protocol templates
Accredited under the WSQ Program
This module is accredited under the WSQ programme as (Develop a Validation Protocol for Equipment PI-PH-308E-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.
Price
S$1,299/month
For 3 Months
S$3,499 in Advance
Save S$150
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Contact Us
Singapore
Call Geraldine: +(65) 6513 9500