You will write a technical report
As part of this course, you will write 1,200 word report on the cGMPs that are required to consistently manufacture safe medicines, vaccines and medical devices for patients. It will 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
Our chemical engineers will give you written feedback on your report.
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 a 4-5 page technical report on the cGMPs that are required to consistently manufacture safe medicines, vaccines, and medical devices for patients.
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.