VOMP 3001- Fundamentals of Pharmaceutical Manufacturing Technologies
This module will give you a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied along with the risk management tools to be used when making decisions that could impact the safety of the medicines being manufactured.
Week 1 – Manufacturing Safe Medicines
Week 2 – GMP’s and 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 and Sterile Manufacturing
Week 8 – PQ OQ IQ
Complete an End of Module Assignment. Write a paper on “Why cGMPs are required for the manufacture of a life sciences product”.
VOMP 3002 – Commissioning & Qualification of Equipment Systems
This module explains the engineering documentation used to specify and design equipment or systems in a manufacturing facility – and how to develop the test protocols (IQ, OQ) to ensure that it operates as intended and meets the regulatory requirements.
Week 9 – Interpreting P&ID’s
Week 10 – System Impact Assessment & Traceability Matrix
Week 11 – Installation Tests & Equipment Verification
Week 12 – Piping Isometrics & Checksheets
Week 13 – Instrument Loops & Checksheets
Week 14 – URS & Functional Testing
Week 15 – Assembling the Validation Protocol
Week 16 – Validation Protocol Final Review
Complete an End of Module Assignment. Write an IQ OQ protocol for a Clean-in-Place system.
VOMP 3018 – Practical Pharmaceutical Bioprocessing
For bulk-chemical and protein therapeutic drugs, the aim of the module is to describe the processing of (1) active pharmaceutical ingredient bulk formulations, (2) drug product finished formulations, (3) container enclosure systems and combination products, and (4) packaging and labeling considerations.
This bioprocessing pilot plant practical module is made up of two 1-day practical which will provide you with the hands-on knowledge and skills associated with operations in a typical modern biopharmaceutical processing facility. We will release preparatory materials before the lab for you to study, review and print out.
Week 18 – Release of the Materials ahead of attending Bioprocessing Pilot Plant Practical:
Week 19 to Week 24 – Reviewing of Materials and attending of practicals
Practical 1 – Facility Design Practical
Practical 2 – Contamination Practical
Practical 3 – Upstream Processing Practical
Practical 4 – Downstream Processing Practical
Complete an End of Module Assignment. Write up of Practicals 1 to 4.
VOMP 3006 – 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.
Week 25 – Controlling Air Quality and Clean Utilities Manufacturing Logistics Calculations
Week 26 – Purified Water Generation and Distribution
Week 27 – Clean Steam and Sterilization
Week 28 – Controlling Material and Personnel flows
Week 29 – Aseptic Processing and Vial Filling
Week 30 – Controlling Cleanrooms and Automation
Week 31 – Quality Systems for Cleanrooms
Week 32 – Construction Lifecycle for New and Modified Facilities
Complete an End of Module Assignment. Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.
VOMP 3008 – Planning a Validation Strategy
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 33 – What’s new in Validation and in Quality
Week 34 – ISPE Guidance Documents and ASTM E2500
Week 35 – Preparing for Process Validation
Week 36 – The Quality Plan, Change Control and the Validation Master Plan (VMP)
Week 37 – Process Validation
Week 38 – The Process Validation Report
Week 39 – Cleaning Validation
Week 40 – Health & Safety at the Operator/Product Interface
Complete an End of Module Assignment. Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.
VOMP 3011 – From URS to PQ – a Validation Project
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 41 to 42 – 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 43 – P&IDs
Week 44 – URS Matrix
Week 45 – Workshop
Week 46 – Workshop
Week 47 – Workshop
Week 48 – Workshop
Week 49 – PQ Template
Week 50 – PQ Template
This eBioPharma Validation course is available worldwide.