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Create a Process Validation Protocol and Write a 1,500-Word Technical Report
As part of your End of Module Assignments:
- Analyze how the regulatory framework for pharmaceutical manufacturing has evolved over recent years.
- Discuss how these regulatory changes will transform pharmaceutical manufacturing from an art (relying on operator intuition) to a science (data-driven, controlled processes).
Additionally, you will document the process of making a simple product as a Process Validation Protocol. The first three questions will guide you in defining the ingredients, equipment, process steps, and testing methods to ensure the product meets the required standards.
You will then create a formal protocol that includes:
- Objectives, Scope, and Responsibilities
- Manufacturing SOP
- Training for process consistency
By documenting this simple process, you will demonstrate your understanding of Process Validation, analogous to ensuring pharmaceutical manufacturing consistently meets quality standards.
Enroll in this course to learn…
- Process Validation Protocol – Generate the protocol & execute a process validation study.
- Validation Master Plan (VMP) – Develop a VMP for a typical product life cycle.
- Critical Process Parameters – Identify the CPP’s and Critical Quality Attributes (CQA’s).
- Audit of Suppliers – Audit suppliers & vendors’ quality plans and documentation.
- Cleaning Validation – Develop a cleaning validation strategy and cleaning validation report.
- Quality Plan – Quality management systems and the quality manual.
You’ll produce a number of deliverables throughout the course including…
- Complete 8-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
End of Module Assignments
- Analyze the evolution of the pharmaceutical regulatory framework and discuss how these changes shift manufacturing from art to science.
- Document a product-making process as a Process Validation Protocol, including objectives, scope, SOP, and training, demonstrating your understanding of Process Validation.
And take the following skills and knowledge back to the workplace…
You’ll be able to:
- Understand and apply ICH guidelines (Q8, Q9, Q10, Q11) to ensure compliance with global regulatory standards in validation and quality management.
- Develop and implement a Validation Master Plan (VMP), ensuring structured and compliant validation processes across different stages of production.
- Participate in audit suppliers and vendors for compliance with quality and validation standards, ensuring that external partners meet required specifications.
- Execute process validation protocols, focusing on critical quality attributes (CQAs) and critical process parameters (CPPs), ensuring robust validation of manufacturing processes.
- Participate in conducting cleaning validation and ensure proper health and safety practices at the operator/product interface, preventing contamination and ensuring process integrity.
Entry Requirements
- You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment.
- You have a solid understanding of the fundamentals of qualification and validation.
Course Price
Hear From People Who’ve Taken This Course
John Ryan
“The course content material is concise and interesting”
“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.”
Ronan Balfe
“I would have no hesitation in recommending these courses”
“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”
Edel Harkins
“Highly recommended to anyone who has been out of the industry for a period of time”
“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”
Delivered by a Practicing Industry Expert
Professor Anne Greene
Senior Lecturer, Technological University Dublin
Professor Anne Greene is a Senior Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students and a Pharmaceutical Projects Manager at Technological University Dublin, Ireland.
In addition, Anne is the Director of the Pharmaceutical Regulatory Science Team and is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter. Her experience ranges from a technical service chemist, Sterling Wintrop Dungarvan, (now GSK), validation manager at startup Wyeth Newbridge, (now Pfizer) and is a Training Director at NIBIRT in Ireland.
Your 10-Week Class Schedule
How We Deliver Our Online Courses without ZOOM Classes
With every GetReskilled ONLINE program;
- Centralized Platform: We use one platform (Moodle) where you can log into your classroom anytime. Each week, you’ll watch videos and complete quizzes, tests, interactive activities, and projects. The course materials are available 24/7, so you don’t have to be online at a specific time. There are No Zoom Classes. Study anywhere, anytime, such as after the kids are in bed or on the weekend.
- Flexible Schedule: Your working schedule may be unpredictable, so we offer flexible delivery. You can slow down, speed up, or pause the program as needed.
- Progress Checks: We release one week’s worth of material at a time and manually check your activity logs at the end of each week to ensure you are keeping up with your work.
- Dedicated Course Leader: Your course leader will:
- Help you create a weekly study plan
- Answer any questions
- Check your progress every Monday
- Follow up regularly to support you until the end of the course.
This all helps us to spot any potential issues early and helps you completely finish the program.
Get a Certificate of Award in “Planning a Validation Strategy”
Once the course is over, complete a written assignment to get certified in Planning a Validation Strategy.
Add details of your certificate to your CV/Resume or your LinkedIn profile.
Price
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
Price
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
Price
£649/month
For 4 months
Or £2,299 in Advance
10 Day Fast Track Option
£3,499
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save £2,299
€699/month
For 4 months
Or €2,699 in Advance
10 Day Fast Track Option
€3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save €2,699
$799/month
For 4 months
Or $2,899 in Advance
10 Day Fast Track Option
$3,999
- Complete this program in 10 days
- Your course leader will check your progress every morning and follow up with you to keep you on schedule.
- We can start you within 24 working hours upon receipt of payment.
- Contact us for details.
Group Price: Enroll a team of five people for the price of four. Save $2,899
Application Deadline: Wednesday 9th July
Program Starts: 16th July
Start Your Application
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Call: +1 (617) 901 9268
Ireland
Call Geraldine: +353 (0)21 2409016
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