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Sterile Products course

Probably the most important and most risky products are the ones that are intended to be sterile. This 2-day course provides a detailed introduction to the key GMP requirements for sterile product manufacturing delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together..
Key InformationWhy Inspired?

A detailed introduction to sterile product manufacturing

Do you need to understand the new EU GMP requirements for sterile products and the areas likely to be looked at during Regulatory Inspection? Do you need to develop a a risk based contamination control strategy? Are you involved in the management and supervision of sterile product manufacturing facilities?  Or, are you involved in support activities, such as environmental monitoring, quality control, quality assurance or site engineering?

Attend this interactive two-day Sterile Products course and leave with an invaluable insight and increased knowledge of the GMP requirements and regulatory expectations essential for effective performance and decision making in the field of sterile products manufacture and control.

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Make a Booking

Our two-day Sterile Products training course is available on the following dates:

Wednesday 10th to Thursday 11th March 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Wednesday 29th to Thursday 30th September 2021

Venue: Your home or workplace using our proven ‘live online interactive’ courseware

Coronavirus Update

Due to the uncertainties involved in travel at the moment we will be delivering all of our public courses using our proven 'live online interactive' technology. Delegate feedback from the courses we delivered in June and July has been just as positive as our classroom courses and in addition, many people have enjoyed not having to travel in these difficult times.

All Dates:

The cost is £1390 plus VAT. Course will be charged in GB pounds. For full details of what is included in the cost see below.

Payment can be made by cheque, electronic transfer, credit or debit card. Payment must be made before the course start date. Either payment or a Purchase Order number will be required to secure a place on the course.

If you plan to pay by credit card then you should first look at this helpful information.

Alternatively, if you want to discuss any aspect of this course or want to reserve a place, please send an email with your enquiry or call +44 1635 866699.

Based outside the UK?

If so, be sure to pick the 'Tax Exempt' options in the payment method list when you are  making a booking. If you are based in the EU then you must also enter your VAT number to qualify to be exempt from VAT.

Group Bookings - discounts of up to 50% 

Book 2 or more individuals from the same company for the same course date to enjoy substantial discounts. The first booking is charged at the full published rate with the second booking charged at full published rate minus 20%. A third or fourth booking is charged at full published rate minus 50%. These discounts are applied automatically when you make a booking.

Key Course Information

Who will the course benefit?

This Sterile Products course is aimed principally at personnel involved in the management and supervision of sterile product manufacturing facilities.  The course is also of great benefit for personnel involved in support activities, such as environmental monitoring personnel, Quality Control and Quality Assurance Officers/ Managers and Engineers.

Course overview

Delegates will learn about the GMP requirements for sterile products and areas likely to be looked at during Regulatory Inspection.  The course provides delegates with an increased knowledge of the GMP requirements for individuals in positions where this is essential for their effective performance and decision making.

Course content

Day 1     Sterility and sterile products

  • The need for sterile products
  • Basic Microbiology
  • Types of contamination
  • Contamination sources
  • Types of manufacture (Aseptic versus Terminal Sterilisation)
  • Sterile product manufacturing, including vials and ampoules, pre-filed syringes and Blow-Fill-Seal
  • GMP requirements for sterile products, including EU GMP Annex 1 and FDA guidelines/ rules
  • Sterilisation and disinfection

Day 2     Cleanroom design, qualification and operation

  • Cleanroom design, qualification and operation
  • HVAC systems – an overview
  • Environmental Monitoring
  • Media Fills
  • Test for Sterility
  • People factors
  • Parametric release of sterile products

Course cost:

£1390  per delegate plus VAT. Course will be charged in GB pounds.

However delegates from outside the UK but within the European Union (EU) will not be charged VAT if they supply their own company’s national VAT number when booking. VAT will not be charged for any delegates coming from outside the EU.

The cost includes:

  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.
  • Full tutor support and access during course times.

    Times: 

    09.00 – 17.00 each day consisting of four 90 minute live interactive online sessions and 3 breaks of at least 30 minutes

Live Online Interactive Training

Stay Safe - Attend from home or whilst at work

With 2 expert facilitators and a maximum of 10 delegates our course will utilise state-of-the art interactive online classroom software that will enable you to:

  • chat online with the facilitators and other delegates
  • raise your 'virtual' hand to ask a question
  • participate anonymously in a poll or survey and see an instant display of the class results
  • undertake exercises on your own or in a group

And best of all, no travel is needed nor a stay in a hotel reducing any risks of COVID-19 and saving you a lot of time, hassle and money. 

As always we will ensure this event is inspirational, enjoyable and educational. See the feedback below:

What is involved?

We will send you a link to the live online interactive course with your joining instructions once you have booked your place. 

You should log into the training session 10-15 minutes before the start time, to ensure that you have set up the courseware  correctly. The course will start precisely on time and it may not be possible to go back over material missed by late arrivals.

Your active participation is expected: everyone will be heard and seen throughout, just as they would be if we were in a room together. To be heard, hear and be seen you will need a microphone, speakers and camera — if you have a modern laptop that’s all you will need. Remember, you’ll need a quiet place to call from and a decent internet connection is a must.

I found the interaction very good by using the chat option as it keeps everyone interested and there was a variety of questions and answers.

Quality / EHS Specialist, DCC VITAL

Great course, although it was virtual I felt we got the same value for money as if it was F2F, a 10 out of 10!!! I will recommend to colleagues

Quality Executive, ABPI

The GMP course was ran very well. Both presenters were very knowledgeable in the area, both for the EU and other countries. I would highly recommend this course to those who are new to the area of GMP, as well as those who just need a bit of a refresher.

 

Training Officer, THORNTON & ROSS

Why choose Inspired Pharma?

Expert Tutors

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992 and is a leading pharmaceutical quality management specialist.  He initially worked for Evans Medical Limited as a Production Development Scientist.  He then moved to Hoechst Marion Roussel where he worked as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.

Over the past 20 years he has worked as a leading pharmaceutical trainer and Quality Management System specialist.  He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems so that they add real-value to organisations.  He has a real passion for training in the pharmaceutical industry and has presented GMP and Quality Management related training courses all over the world.  He is an IRCA registered GMP Lead Auditor and regularly performs audits of pharmaceutical companies and their suppliers.

Delegate Feedback

A superb course

QA Officer, PHE

Excellent – tutor kept us interested

Microbiologist, MOORFIELDS PHARMACEUTICAL

Very good, informative and well presented

Operator, TEVA RUNCORN

A very good overview

Production Scientist, PHE

Informative and enjoyable

Operator, MOORFIELDS PHARMACEUTICAL

Delivered well – information very relevant to my role

Operator, TEVA RUNCORN

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About Inspired Pharma

We help people in Pharma organisations to continually improve their regulatory systems to gain competitive advantage and ensure compliance.

We offer a wide range of highly praised and respected classroom and online training courses and also provide our global pharma clients with consultancy support. Our classroom courses are available on a public schedule and also can be customised for inhouse delivery at a client site.

Quick Links

Find your way quickly to any part of our website by selecting any of the links in this section:

Forthcoming Public Courses

All of our public courses are being delivered using our proven 'live online interactive' courseware enabling you to attend the course from your home or workplace and be heard and seen throughout, just as you would be if we were in a room together.

Click on course name for full details:

2020

November

24 Problem Solving

30 Pharma GMP Lead Auditor

December

14 Pharma GMP Lead Auditor

2021

January

12 Internal Auditor

18 Pharma GMP Lead Auditor

26 Responsible Person

February

01 Pharma GMP Lead Auditor

03 Data Integrity

08 Pharma GMP Lead Auditor

23 Documentation & Records

March

09 Good Distribution Practice

10 Sterile Products

15 Pharma GMP Lead Auditor

23 Advanced GMP

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

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Each course typically consists of 10-20 minute chapters of content followed by a quiz based assessment. The QP courses feature tutor assessment too. The learning is accessed over the internet using desktop computers, laptops, tablets and even smartphones.

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