This GMP Training Course is Right For You If;
- You want to learn how safe medicines and medical devices are made in a regulated GMP environment.
- You work in academia or a research laboratory and need to work with professionals in the pharmaceutical and med device manufacturing sector.
- You have to train your team on how safe medicines and medical devices are made in a regulated GMP environment as part of a GMP compliance, GMP refresher or GMP induction training programme.
Minimum Entry Requirements
- You have one of the following qualifications or work in any of the following:
- PhD, Masters, Degree or Diploma in Biochemistry, Microbiology, Molecular Biology, Laboratory/Science
- Management or Engineering Consultant
- Engineers or Technicians
- Quality Control or Quality Assurance
- Frontend/Backend/Full Stack or Enterprise Software Developer
- Logistics – Supply Chain Managers, Procurement
- Business – MBA’s, Finance, Accountants, etc
- Sales – Pharma Sales, Business Development, etc
- Packaging and labelling industry
- HR/Recruitment Specialists focused on life sciences, pharmaceutical, biotech or medical device industry
Note: If you want to retrain for an entry-level job in Pharmaceutical Manufacturing, check out our Conversion Course into Pharma Manufacturing.
If you want to retrain for a new career in the pharmaceutical manufacturing industry…
Choose from the following backgrounds to find the most suitable course.
Enroll in this course to learn…
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems, regulation and validation
- Industry regulations and guidelines for GMPs – including, FDA GMPs for the United States, EMA GMPs for European Union, ICH, and PICs GMP regulation
- FDA medical device rules – medical device regulations & guidelines
- GMPs vs ISO 9001:2015 – what’s the difference and why we use both
- Process validation and documentation – design and verification of manufacturing systems
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
- Supporting technologies – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
- Introduction to Quality Risk Management (QRM) – and the importance of risk management and the basic steps involved in its application
- Working in a cleanroom environment – layout, classification, gowning and monitoring
- Professional Writing Skills Program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry
You’ll produce a number of deliverables throughout the course including…
- Complete the following 2 Quality Risk Management Tool workshops where you will learn to use worst-case scenario planning to figure out what could go wrong in the manufacturing process and come up with steps to mitigate those risks.
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
- Complete four-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.
- Complete an end of module 4-5 page assignment to include:
- The key requirements of a quality management system
- The cleaning validation sequence and how to determine cleanliness levels
- The documentation of a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk and controlling risk.
- The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
- The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
- The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment
And take the following skills and knowledge back to work…
- You’ll have a foundation in how safe medicines and medical devices are made in a regulated GMP environment.
- You’ll be able to participate in root cause analysis projects.
- You’ll have enough technical knowledge and understanding of the quality culture necessary to work in this environment.
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You’ll have the written communications skills to properly write reports and reference and cite source material in a manner that is consistent with the professional norms of this industry.
- You’ll be able to work with professionals in this sector without feeling lost or intimidated by the specialised terms and frameworks used in this sector.