Pharmaceutical Validation Training Course (ONLINE) – For More Senior Validation, CQV and C&Q Roles

Description

Want a more senior validation engineer, CQV or C&Q job with a higher salary? Take our level 7 University Certificate in Validation Training Course. Develop process validation protocols, Plan a validation strategy. Develop a validation master plan for the entire lifecycle of a product. Give yourself a competitive edge in the marketplace. Developed in consultation with the pharma industry including Pfizer and MSD. University Accredited by TU Dublin Ireland.

UNIVERSITY ACCREDITEDApply NOW & retrain more senior validation, CQV or C&Q roles

University Accredited by TU Dublin Ireland

For a validated process to meet the requirements of a regulatory audit.

From the development of a validation master plan for the entire lifecycle of a product.

Give yourself a competitive edge when applying for jobs.

You’ll have working knowledge of the everyday activities of a Validation Team.

Minimum Entry Requirements:

You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in Validation”

NOTE:

If you answer “NO” to any of the 4 questions above, you will first need to take our Equipment Validation Training Course (ONLINE) – For Starter Validation Roles and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Equipment Qualification Protocol. This program covers all the entry requirements above.

In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script

View Full 30 Week Syllabus

The more validation work experience you have, the better positioned you’ll be to successfully apply for more senior roles upon completion of the program. Here are some of the most common job titles we see advertised and the expected salaries.

Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.

Some companies might call this role:

Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.

Some companies might call this role:

This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.

Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations for non validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.

Some companies might call this role:

In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.

Week 1 – Controlling Air Quality and Clean Utilities Part 1Week 2 - Controlling Air Quality and Clean Utilities Part 2Week 3 – Purified Water Generation and Distribution Part 1Week 4 – Purified Water Generation and Distribution Part 2Week 5 – Clean Steam and SterilizationWeek 6 – Controlling Material and Personnel FlowsWeek 7 – Aseptic Processing and Vial FillingWeek 8 – Controlling Cleanrooms and AutomationWeek 9 – Quality Systems for CleanroomsWeek 10 – Construction Lifecycle for New and Modified FacilitiesComplete the Following Activities & WorkshopsComplete an End of Module Assignment

This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.

Week 11 – What’s new in Validation and in QualityWeek 12 – ISPE Guidance Documents and ASTM E2500Week 13 – Preparing for Process ValidationWeek 14 – The Quality Plan, Change Control and the Validation Master Plan (VMP)Week 15 – Process ValidationWeek 16 – The Process Validation ReportWeek 17 – Cleaning ValidationWeek 18 – Health & Safety at the Operator/Product InterfaceWeeks 19 & 20 - Complete an End of Module AssignmentComplete the Following Activities & Workshops

This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script.

Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template

This CPD Certificate (Continuous Professional Development) is university-accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end-of-module assignments.

This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.

I’d recommend this course to anyone that wants to work in the Pharmaceutical and Medical Device Manufacturing industry and is interested in building a successful career in this area. The online experience is working well for me as I study around work and family commitments.

The companies I applied for were very impressed. I am currently working in Boston Scientific manufacturing Balloon Catheters for Gallstone patients.

Having faced a career change in the middle of an economic downturn, I lost some of myself confidence and needed a major boost. The area of Biopharmaceutical operations and validation was of interest to me as it does play an important role in the pharmaceutical industry at present.

I have now been working at Johnson and Johnson Vision Care as a Validation Engineer and I look forward to putting what I have learned into practice.

I found the course to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.

I have worked in the Medical device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.

Read over 55 reviews and graduate success stories like these.

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

Dr. Joe Brady is 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 institution.

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

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.

With every GetReskilled ONLINE program;

This all helps us to spot any potential issues early and helps you completely finish the program.