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A-Z of Sterile Products Manufacture

NSF International, Health Sciences
Course summary
4-5 days
2,800 - 2,900 GBP excl. VAT
English
Full time
Online courses, York
Next available date: 01/11/2021 09:00 - York

Course description

A-Z of Sterile Products Manufacture 

The original and still the best! We have been hosting this highly participative and extremely popular four-and-a-half-day sterile products training course for over 30 years and have trained literally thousands of pharmaceutical industry professionals around the world in that time. Come and learn the key scientific, technical and regulatory challenges associated with the manufacture of sterile products and how to implement an effective and compliant quality system to assure the safety and quality of the products that you make. Whether you need to meet EU, FDA or any other regulatory agency’s needs, this course will give you the knowledge, skills and tools to succeed!
From air change rates to Z values and everything in between!

When a pharma product is administered parenterally, it bypasses the body’s natural defence mechanisms and any quality defect has the potential to cause serious harm to the end user. It is easy to overlook the key quality attributes of the sterile products or not appreciate which parts of your pharmaceutical quality system (PQS) provide both identification and mitigation of risk.

This Royal Society of Chemistry (RSC) approved course concentrates on how product quality is assured via practical and interactive review of the science and compliance behind sterile products manufacturing.

Suitability - Who should attend?

The Aspiring Qualified Person

  • Our training is generally considered as the best available and our QPs are held in high regard within the industry.
  • As well as being accepted in the UK, our training courses are well known and accepted by several other EU countries, including Ireland, the Netherlands, Austria, Hungary and Malta.
  • You are more likely to become a QP with us than with any other training provider!

The Pharmaceutical Technical Professional

  • Not all the people attending these courses intend to become QPs. Many use the training to develop as technical managers within other areas of pharmaceutical manufacture and control.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development. Taken with some of our other QP modules, this course is designed to lead to Postgraduate Certificate, Diploma and MSc qualifications.

Training Course Content

Course Outline

Regulatory Standards for Sterile Products:

  • What they are
  • How to interpret
  • Regulatory hot topics: Present and future

Creating the ‘Controlled Environment’

The design, validation, operation and maintenance of:

  • Cleanrooms
  • Isolators, RABs, BFS
  • Sterile preparation and formulation
  • Aseptic and TS production methods
  • Environmental monitoring – the what, the why and the how
  • Routine disinfection – a quality critical activity!

Critical Utilities

The design, validation, operation and maintenance of:

Steam

  • Water (from bore hole to water for injection)
  • Sterilization Processes: Everything you need to know
  • Moist heat (autoclaves)
  • Dry heat (ovens and tunnels)
  • Filtration
  • Irradiation
  • VHP surface sanitization

Process Simulations (Media Fills): The what, the why, the how and ‘what if’

  • Regulatory requirements
  • How to design media fills ‘fit for purpose’
  • Best industry practice
  • What to do when they ‘fail’!

Container Integrity and Particulate Inspection

  • How to validate and test
  • How to manage failures - from root cause investigation to CAPA implementation

People Issues

  • How to select, educate and manage cleanroom staff
  • Gowning and good aseptic practices
  • How to motivate and lead by example, understanding, promoting and enforcing
  • Good aseptic behaviors

Problem Solving and Troubleshooting (dealing with the unplanned)

  • What to do when things go wrong

Course delivery details

If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.

All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Discounts

Multiple participant discounts available. Discounts also offered to NHS staff, regulators and charities.

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Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.

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About provider

NSF International, Health Sciences

NSF International provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are...


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Contact info

NSF International, Health Sciences

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

Reviews

Average rating 4.6

Based on 5 reviews.

S. Ambrosini
An excellent course. It was interactive with practical examples, the speaker was very prepared. A good refresh for audience of different levels, so far it is the best course I have ever attended .
M. Forkan
Excellent training with expert knowledge and a great balance of practical and theoretical content.
Brandy Koslop
This course has exceeded all expectations. First time a training course has struck the right balance between learning the modules and having good and productive interactions between classmates. Well done to all of you for designing such a useful course.
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