Professional Training
4.6 (5 Reviews)

A-Z of Sterile Products Manufacture

4-5 days
4-5 days
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Course description

A-Z of Sterile Products Manufacture

From air change rates to Z values and everything in between!

For over 30 years we have hosted this highly participative and popular sterile products manufacturing training course. Thousands of pharmaceutical industry professionals around the world have benefitted from learning about key scientific, technical and regulatory challenges associated with Good Manufacturing Practice (GMP) of sterile products manufacturing. Whether you need to meet EU, FDA or any other regulatory agencys needs, this course gives you the knowledge, skills and tools to succeed.

A pharma product administered parenterally bypasses the bodys natural defense mechanisms. Consequently, any quality defect could potentially cause serious harm to the end user. Linking everything you do to providing a safe and effective formulation to the end user is critical. Our manufacturing sterile products training course concentrates on how product quality is assured via practical and interactive review of the science and compliance behind sterile products manufacturing.

Outcome / Qualification etc.

Completion of this sterile products training course will enable you to:

  • Describe a typical sterile production process and the facility, equipment and utilities associated with sterile product manufacture
  • Know what aspects require detailed definition, validation and ongoing monitoring
  • Know the typical failure modes and how to determine most probable root cause and mitigation strategies
  • Understand how the key attributes of a sterile product impact:
  • The pharmaceutical quality system
  • The organization
  • The management oversight process
  • Risk management and mitigation
  • The end user or patient

Training Course Content

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:


  • 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

Customer Outreach Award


We believe that it should be easy for you to find and compare training courses. 

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.


Average rating 4.6

Based on 5 reviews.
Reviews are published according to our review policy.
Write a review!
S. Ambrosini
05 Apr 2019
Good refresher

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 h...

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M. Forkan
05 Apr 2019
Excellent training

Excellent training with expert knowledge and a great balance of practical and theoretical content.

Brandy Koslop
22 Sep 2017

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 be...

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

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