Our learners work for the world’s biggest pharma and medical device companies
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.
Enroll in this program to learn…
- How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
- How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
- How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
- The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do base on the User Requirement Specifications).
- How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
- How to qualify equipment, instruments and piping systems and automation controls.
- How to document all of these steps in validation protocol which you will develop as your end of module assignment.
You’ll learn how an IQ OQ PQ Validation Protocol is produced to commission and qualify a clean-in-place system…
The protocol will detail the following elements;
- Product characteristics – showing what your system is looking to achieve/produce
- Production equipment – detailing the equipment necessary
- Test scripts and methods – telling you the steps involved in conducting a test
- Test parameters and acceptance criteria – defining acceptable test results
- Test checksheets – documenting and recording the test results
- Final approval – documenting that the validation process has been successfully carried out
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.
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
Learn the systems, protocols, tools, vocabulary, and best practices from our Lecturer’s who have had decades of on the job experience.
Course Leaders
Your Course Leaders will onboard you on the program, and help keep you motivated throughout the course.
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!
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.”
Delivered by an Industry Expert
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 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.
Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems
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$398
Try Us Risk FREE for 7 Days 100% Money Back Guarantee.
Application Deadline: Wednesday 16th February 2022
Course Starts: 24th February
Got More Questions?
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.
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 for 6 months.
Yes, this course is relevant to both the pharmaceutical and medical device industries.