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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 InformationCourse Dates

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.

Some unique features of our 2 day Sterile Products course: 

Lively and highly interactive course

Our 2-day format is designed to ensure that  this is a lively and highly interactive course with practical workshops and exercises throughout the programme. See the incredible feedback from delegates about our ‘live online interactive ‘ courses  in this article.

Maximum class sizes

For maximum interactivity and effectiveness, our class size is limited to  either 10 delegates  (live online interactive)  or 12 delegates (classroom) with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry.

Make a Booking

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

2021

Venue for all dates: Your home or workplace using our proven ‘live online interactive’ courseware. From the list below select the date you want to make a booking (dates in blue are ‘Waiting List’ only):

Wednesday 5th to Thursday 6th May 2021

Click here to book

Wednesday 29th to Thursday 30th September 2021

Click here to book

Booking details

Select the tabs below to find out all the details you need to know to make a booking:

Course cost

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.

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.

What's included in cost

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.

Payment

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 RP training 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.

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

Key Course Information

Is this course right for you?

Click on the tabs below to find out if you will benefit from attending this course:

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.

So that we can give the delegates the right amount of time and attention – we limit this course to a maximum of 10 delegates.

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

Course Details

Click on the tabs below for more details on the content of the course:

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.

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

Live Online Interactive Training

This course is currently only available using our proven ‘live online interactive’ format. Select the tabs below to find out more:

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.

Why choose Inspired Pharma?

Expert Tutors

sterile products courseAndy Martin started working in the Pharmaceutical industry in 1985 for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager and then latterly as Microbiology Manager for Catalent Pharma Solutions.  In 2012 he became a consultant specialising in Pharmaceutical Microbiology and Quality Systems.

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

Recent independently verified reviews about this course from Reviews.io

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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:

2021

March

09 Good Distribution Practice

15 Pharma GMP Lead Auditor

23 Advanced GMP

April

19 Pharma GMP Lead Auditor

20 Responsible Person

26 Pharma GMP Lead Auditor

May

05 Sterile Products

20 Internal Auditor

17 Pharma GMP Lead Auditor

June

07 Pharma GMP Lead Auditor

08 Good Manufacturing Practice

09 Data Integrity

10 Problem Solving

28 Pharma GMP Lead Auditor

Online courses available anytime anywhere 

Data Integrity

Good Distribution Practice (GDP)

Good Manufacturing Practice (GMP)

Pharma Quality Management Systems module

QP Medicinal Chemistry & Therapeutics module 

QP Quality Management Systems module

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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