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This Course is For You If;
And..
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Enroll in this course to learn…
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
- Purified water generation – storage and distribution that underpin aseptic/sterile processing
- Clean steam – water for injection, storage and distribution that underpin aseptic/sterile processing.
- Instrumentation process control design – for the generation and distribution of clean utility systems.
- Cleanroom layout design – layout and classification along with the environmental controls pressure profiles
- Aseptic processing – lyophilization and how vials are filled in an aseptic environment
- Quality systems – for cleanrooms for both EMA and FDA guidance on aseptic processing.
You’ll produce a number of deliverables throughout the program including…
- Complete 8-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 assignment to include the following:
- Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
- Describe process support and utility systems encountered on a typical biopharmaceutical facility
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
- Describe the similarities and differences between pharmacopoeia grade purified water (PUW) and water for injection (WFI).
And take the following skills and knowledge back to work…
- You’ll have a strong foundation in how safe medicines and medical devices are made in a GMP regulated manufacturing environment.
- You’ll understand the air, clean water and steam systems that underpin aseptic/sterile processing.
- You’ll understand cleanroom layout design, layout and classification and the environmental controls pressure profiles
- You’ll have the technical knowledge and understanding of the quality culture necessary to work in this environment
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See Course Price
Entry Requirements
- You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment.
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Hear From People Who’ve Taken This Course
John Ryan
“The course content material is concise and interesting”
“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”
Ronan Balfe
“I would have no hesitation in recommending these courses”
“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”
Edel Harkins
“Highly recommended to anyone who has been out of the industry for a period of time”
“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”
Noel O’Brien
“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”
Anne Reilly
“Very important to do a course if you have been absent from workplace for a relatively long period. It just gives you the confidence to do interviews etc.”
Louise McManus
“Excellent course, well set out.”
Andy Wnuk, MSc (Eng) MIEI
“Along with the technical training in I would rate the course 10 out 10 and would highly recommend to others, very interesting, informative and very well presented. Relevant totally to my needs and expectations.”