Certificate in Science in e-(Bio)Pharma Chem with Facility Design

Course Syllabus

Overview of Course Module Timelines:

Module 1 – VOMP3001: Fundamentals of Pharmaceutical Manufacturing Technologies (8 weeks)
Week 1: Manufacturing Safe Medicines
Week 2: GMPs & Quality Management Systems
Week 3: Good Automated Manufacturing Practices (GAMP)
Week 4: API Manufacturing Technologies
Week 5: Biopharmaceutical Manufacturing Technologies
Week 6: Cleaning Validation
Week 7: Medical Devices & Sterile Manufacturing
Week 8: PQ OQ IQ
Weeks 9 – 13: Completion of assignment (in conjunction with writing skills module – see below)

Module 2 – GRS1002: Advanced Writing Skills Module (4 weeks)
Week 9: Understanding Your Audience
Week 10: Complete Your Document Outline
Week 11: Complete Your First Draft
Week 12: Complete Your Final Essay
Week 13: Complete Associated Written Question Booklet

Module 3 – VOMP3006: Principles of Pharmaceutical Facility Design (13 weeks)
Week 14: Controlling Air Quality and Clean Utilities Part 1
Week 15: Controlling Air Quality and Clean Utilities Part 2
Week 16: Purified Water Generation and Distribution Part 1
Week 17: Purified Water Generation and Distribution Part 2
Week 18: Clean Steam and Sterilization
Week 19: Controlling Material and Personnel Flows
Week 20: Aseptic Processing and Vial Filling
Week 21: Controlling Cleanrooms and Automation
Week 22: Quality Systems for Cleanrooms
Week 23: Construction Lifecycle for New and Modified Facilities
Week 24 – Week 26: Completion of end of module assignment

Module 4 – VOMP3002: Commissioning & Qualification of Equipment & System (12 weeks)
Week 27: Interpreting P&IDs
Week 28: System Impact Assessment & Traceability Matrix
Week 29: Installation Tests & Equipment Verification
Week 30: Piping Isometrics & Checksheets
Week 31: Instrument Loops & Checksheets
Week 32: URS & Functional Testing
Week 33: Assembling the Validation Protocol
Week 34: Validation Protocol Final Review
Weeks 35 – 38: Completion of end of module assignment

Module 5 – GRS1001: Advanced Career Coaching and Job Readiness (4 weeks)
Week 39: Understanding the industry and your skills
Week 40: Writing your CV
Week 41: Networking, Interviewing and Psychometric Tests
Week 42: Complete End of Module Assignment

Module 6 – VOMP3003: Chemistry for APIs (8 weeks)
Week 43: Chemistry & Matter; Atomic Theory
Week 44: The Periodic Table and Bonding
Week 45: Stoichiometry
Week 46: Acids and Bases Recrystallisation
Week 47: Introduction to Organic Chemistry and Overview of Safety in Chemical Laboratories
Week 48: Virtual Practical 1 (Seperation of a 3 component mixture) and Virtual Practical 2 (Synthesis of Aspirin)
Week 49: Virtual Practical 3 (Preparation for Volumetric Analysis) and Virtual Practical 4 (Analysis of Baking Soda)
Week 50: Online Exam on Chemistry Course Work

Summary of Module Aims:

There are 4 technical modules and 2 skills modules delivered throughout the year:

VOMP3001 – Fundamentals of Pharmaceutical Manufacturing Technologies
This will give you a broad understanding of current Good Manufacturing Practices (cGMPs) – this is the set of unique regulations that pharmaceutical and medical device manufacturers legally have to follow to make sure they’re making safe products. This is the baseline of knowledge that employers in this industry require employees to have.

GRS1002 – Writing Skills Module
This module equips you with a high level of written communication skills. You’ll study this as you’re writing your end of module assignment for technical module 1. Not only will it walk you through the writing process for that (ensuring that you present your ideas in a way that gives you the best chance at achieving great marks), it’s also a highly practical development of the writing skills you’ll need for any workplace.

VOMP3006 – Principles of Pharmaceutical Facility Design
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.

VOMP3002 – Commissioning and Qualification of Equipment and Systems
This module will teach you about the commissioning and qualification of equipment and systems in a Pharma manufacturing environment. As part of this, you will learn to populate your own validation protocol. You will also learn to read P&IDs, Piping Isometrics & Electrical Loop Drawings. Being able to confidently talk about these concepts will definitely impress employers and set you apart from other candidates.

GRS1001 – Job Hunting Skills
This skills module is the one that really gives your pharma job hunt a boost. We’ll walk you through the pharma job hunting process step-by-step, showing you the types of jobs to consider, how to really catch an employer’s attention with your application, and how to confidently interview within this industry. As soon as you’ve finished this module and your first technical module, you can put it into practice and start making applications.

VOMP3003 – Fundamentals of Chemistry for the Pharmaceutical Industry
This module will give you a foundation in the general chemistry you’ll need to understand for the manufacture of medicinal products – and is a key part of the underpinning theory behind a job in the Pharma industry

VOMP3001 – Fundamentals of Pharmaceutical Manufacturing Technologies

AIM:
The aim of this module is to give students a broad understanding of what current good manufacturing practices (cGMP) apply to the manufacture of medicinal products, and how this relates to validation. It will consider industry standard guidelines and best practices for determining particular validation approaches. The course is based on designing validation strategies that apply to the principles of quality by design, risk management and continuous improvements as per the draft ICH (International Conference on Harmonisation) guidelines Q8, Q9 and Q10

CONTENT:

• Introduction to the manufacture of medicinal products. Why validation? and the need for current Good Manufacturing Practices (cGMP)
• The validation life-cycle
• ISPE Baseline Guide 5 ‘Commissioning and Qualification’
• Good Automated Manufacturing Practices (GAMP5)
• Validation of finished pharmaceuticals and active pharmaceutical ingredients (API)
• Validation of biopharmaceuticals
• Validation of medical devices
• Cleaning validation
• Harmonised regulatory compliance
• cGMPs for the 21st century

OUTCOME:

On completion of this module the learner should be able to:

1. Determine what cGMPs apply to the manufacture of medicinal products in various countries in accordance with regional regulatory expectations.
2. Have a good grasp of the industry standard guidelines ISPE Baseline Guide 5 ‘Commissioning and Qualification’, and GAMP5 Good Automated Manufacturing Practice
3. Define what equipment systems require commissioning and what systems should be qualified in the context of new manufacturing processes.
4. Apply a range of risk-management tools in making regulatory based decisions
5. Have an appreciation for the similarities and differences for the manufacture of active pharmaceutical ingredients (API), biopharmaceuticals, and medical devices

FORMAT:
Delivered fully online by way of 8 “Weekly Sessions” with each “Weekly Session” housing a series of “Topics” with each “Topic” having a clear 4-Step Sequence:
Step 1 – Series of “Warm-Up” Questions (not graded)
Step 2 – Watch Pre-recorded video(s) from the lecturer
Step 3 – Download and Read Course Notes
Step 4 – Series of “Self-Assessment” Questions (not graded)

GRADED ASSIGNMENT:

• 3000 Word/10 Page Essay (70%) – Please see GRS1002 “Advanced Writing Skills”, as you will be taught how to write this essay during this module.
• Series of Questions (30%)

GRS1002 – Advanced Writing Skills

AIM:
This course is specifically designed to walk you step by step process to improve your written communication skills in the workplace. With the job market in its current state, having these key skills up your sleeve is a must. The Advanced Writing Course gives you all the advice, tools, and tips you need for successful written communication at work and in academia. You will be covering this module as you write your VOMP3001 3,000 word essay so if this is your first long piece of writing in a while, we are going to be guiding you through how to get the grade you deserve. And just in case you are worried – don’t worry – this is most definitely not like the English classes you remember from school.

CONTENT:

• Finding your workplace context
• Mapping & Planning
• Building credibility
• Organizing your ideas
• Paragraphs
• Gathering Information
• Turning your document outline into a first draft
• Elevate your writing
• Proving your point
• Tone
• Clarity & Conciseness
• Proofread
• Finishing Touches
• Implementing the editing checklist

OUTCOME:
On completion of this module the learner should be able to:

1. Identify which of your work tasks this course will help with
2. Ask 3 key questions to guide your writing
3. Tailor a set of information differently for different audiences
4. Create a writing plan
5. Know how to build credibility in your professional writing
6. Decide whether a source is credible and suitable for your writing project
7. Turn your writing plan into a document outline
8. Write paragraphs that walk a reader through even the most complicated idea in a way that’s easy to follow
9. Implement the essential tips for writing sentences that are clear, concise, and minimise misunderstandings
10. Implement the essential tips the will elevate your writing and help you avoid ambiguity
11. Write introductions that catch a reader’s attention
12. Write conclusions that lead a reader to take the action you want them to
13. Confidently turn a document outline into a first draft
14. Use a variety of templates in your future writing tasks
15. Use the editing checklist to quickly and effectively edit your writing

FORMAT:
Delivered fully online by way of 4 “Weekly Sessions” with each “Weekly Session” containing a range of tasks to deliver that week’s learning outcomes. Tasks include:
Step 1 – Download and Read Course Notes
Step 2 – Watch Pre-recorded video(s) from the lecturer
Step 3 – “Self-Assessment” Question (not graded)
Step 4 – Read supporting material linked from the reading list
Step 5 – Complete series of personal implementation tasks

ASSESSMENT / ASSIGNMENT:

• The assignment for this module is to utilize these skills on your VOMP 3001 3,000 word essay. We will be looking to ensure that you use these processes to write your VOMP 3001 essay.

VOMP3006 – Principles of Pharmaceutical Facility Design

AIM:
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.

CONTENT:

• Mass Balances and the Process Flow Diagram
• Clean Utility Generation and Distribution System Design
• Process Design for Equipment Sizing
• Cleanroom layout and Environmental Controls design for material and personnel flows
• Mechanical-piping and electrical-instrumentation design, process control and automation
• Aseptic processing and viall filling
• Site master planning and the project lifecycle for new equipment and systems

OUTCOME:

On completion of this module the learner should be able to:

1. Define the Cleanroom layout and the Environmental Controls pressure profiles necessary to meet the materials and personnel flows of a regulated manufacturing environment
2. Define the piping, instrumentation and process control design for the generation and distribution of clean utility systems
3. Understand the Quality Systems approach to Pharmaceutica manufacturing
4. Describe the aseptic processing requirements of a vial filling operation

FORMAT:
Delivered fully online by way of “Weekly Sessions” with each “Weekly Session” housing a series of “Topics” with each “Topic” having a clear 4-Step Sequence:
Step 1 – Series of “Warm-Up” Questions (not graded)
Step 2 – Watch Pre-recorded video(s) from the lecturer
Step 3 – Download and Read Course Notes
Step 4 – Series of “Self-Assessment” Questions (not graded)

GRADED ASSIGNMENT:

• Write a 3,000 word report on a site master plan for a new aseptic manufacturing facility, and the design of its environmental control and clean utility systems.

VOMP3002 – Commissioning and Qualification of Equipment and Systems

AIM:
The aim is to define the testing requirements for a range of typical mechanical, process, electrical and automation systems used in the manufacture of medicinal products. This will range from standard good engineering practices (GEP), standard commissioning approaches, and specific regulatory focused qualification testing.

CONTENT:

• Traceability matrices: from URS to specifications, and from URS to PQ
• Equipment verification check sheets
• Instrument verification check sheets
• Piping verification check sheets
• Computer system verification check sheets
• Defining the contents of FAT, SAT, DQ, IQ, OQ and PQ protocols using risk management, and determining the structure of protocol summary reports
• Facilities, cleanroom and HVAC validation protocols
• Validation of process critical utilities (e.g.: SIP, WFI, DDW, etc.)
• ERES assessment (21 CFR Part 11) of automated packages: mitigation and remediation strategies and periodic re-assessment
• Cleaning validation protocols

OUTCOME:

On completion of the modules the learner should be able to:

1. Prepare and execute validation testing protocols
2. Qualify equipment, instruments and piping systems, along with automated systems and building facilities.
3. Have a clear understanding about what design specifications are required to generate testing scripts, and when and where they require generation and execution during the project lifecycle.

FORMAT:
Delivered fully online by way of 8 “Weekly Sessions” with each “Weekly Session” housing a series of “Topics” with each “Topic” having a clear 4-Step Sequence:
Step 1 – Series of “Warm-Up” Questions (not graded)
Step 2 – Watch Pre-recorded video(s) from the lecturer
Step 3 – Download and Read Course Notes
Step 4 – Series of “Self-Assessment” Questions (not graded)

GRADED ASSIGNMENT:

• Develop an Installation and Functional Verification Protocol for a Hot Detergent and Hot PUW Generation and Distribution System

GRS1001 – Advanced Job Hunting

AIM:
The aim of this module is to provide students with the skills and processes needed to successfully conduct a job hunt within the pharmaceutical and medical device manufacturing industries. It will use a variety of tasks, techniques and learning outcomes over 4 weeks to focus and progress the job hunting capabilities of participants as well as giving all students a baseline knowledge of their local pharmaceutical and medical device environment.

CONTENT:

• Exploring pharmaceutical company departments and job roles to establish the correct focus for each individual
• Improvement in understanding of the industry at both a global and a local level
• Introduction to relevant companies as well as regulatory and professional organisations
• Systematic assessment of current skills
• Networking – both on and offline
• CV and cover letter writing
• Social media for job hunting
• Speculative applications
• Tailoring the application process to maximise the impact of each job application
• Interview preparation

OUTCOME:
On completion of this module the learner should be able to:

1. Discuss their local pharmaceutical and medical device manufacturing industry
2. List the departments and job roles where their skills are best suited
3. Understand their current skill set and how to discuss that with pharmaceutical employers
4. Network effectively both on and offline
5. Write a CV and cover letter that are highly tailored to a job advert
6. Write a speculative application and have a list of local companies appropriate for such an application
7. Prepare for an interview

GRADED ASSIGNMENT:

• Completion of a Fillable PDF
• Completion of an end-of-module assignments based on a sample job advert

VOMP3003 – Fundamentals of Chemistry for Active Pharmaceutical Ingredients

AIM:
The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of API required for the manufacture of medicinal products. Please note, that this module includes virtual lab practicals. You will not need to travel anywhere to complete these practicals. You will be able to complete them from the comfort of your own home.

CONTENT:

Theory Part of Module 

• Introduction to Atomic theory, Solid state: Amorphous and crystalline
• SI system of units, Mole concept, Reactions and balancing equations.
• Stoichiometry:- limiting reagents, percentage yields. Concentration, molarity and percentage composition.
• Acids and Bases.
• Kinetics:- rate laws, reaction order and activation energy.
• Introduction to organic chemistry:- functional groups and isomerisation.
• Concepts underpinned by a practical component.

Virtual Laboratory Practical

• Safety in the Lab
• Organic compound Recrystallisation
• Preparation of Sodium Carbonate
• Synthesis of Aspirin

OUTCOME:

On completion of this module the learner should be able to:

1. Understand the structure and arrangement of elements in the periodic table.
2. Have an understanding of bonding and crystal structure.
3. Be familiar with SI units, concentration, balancing chemical reactions and chemical calculations.
4. Have a basic understanding of the principles of organic chemistry: functional groups and isomerism.
5. Appreciate the basic laboratory principles underpinning recrystallisation, distillation and volumetric analysis.

FORMAT:
Delivered online over 8 Weeks

• Part 1: Theory Lessons 1 – 5
• Part 2: Virtual Practicals Lessons 6 – 10

ASSIGNMENT BASED ASSESSMENT:

1. Problem sheets 1, 2&3, 4&5
2. Problem sheets 7, 8, 9 and 10
3. Two hour Open Book Online Exam