For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699 info@inspiredpharma.com

Sterile Products - Annex 1 update training course

The original objectives for the update of annex 1 included the need to incorporate risk management in the manufacture of sterile products, to address the advances in technology for clean spaces, increased use of closed and single use systems and to address a number of historical ambiguities and inaccuracies.
So what are the main changes? This half day course sets out to look at these and provides delegate with an opportunity to discuss how it's implementation will impact their organisation.
Key InformationCourse Dates

A detailed review of the changes to Annex 1 related to sterile product manufacturing

Do you need to understand the new annex 1 requirements for sterile products? If you need to develop a a risk based contamination control strategy or involved in the management and supervision of sterile product manufacturing facilities then this half day update course is essential. This training course is intended for personnel working in Quality Assurance, Sterility Assurance, Production, Facilities, Engineering, Auditors, Qualified Persons and all support functions involved in contamination in sterile environments.

Some unique features of our half-day day Sterile Products course: 

Lively and highly interactive course

Our half-day format is designed to ensure that  this is a lively and highly interactive course 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)  with at least two tutors. The quality and effectiveness of our courses is unrivalled in the industry. This is a training course – NOT A SEMINAR.

Training to inspire you

Our courses receive fantastic reviews. Some ‘nuggets’ from our reviews.io website for our 2-day Sterile Product course are shown opposite/below. Use the chevrons under the ‘nugget’ to navigate all of them. See the full quotes further down this page.

Make a Booking

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

This pharmaceutical disinfection and cleaning webinar is available for in-house presentation, either on-site or virtually.  Please contact us for further details.

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 £295 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:

  • A downloadable PDF file 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 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.

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 – 13.00 with  breaks of at least 20 minutes to keep everyone fresh.

Course Details

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

Course Overview

This training will outline the clauses which have been newly introduced or modified. Question and answer sessions  will be facilitated to determine the impact this may have on your facility and operations.

Course contents

The course will otline the major changes for

    • Quality Risk Management
    • Contamination Control Strategy (CCS)
    • Production and new technologies
    • Personnel controls such as gowning and training
    • Environmental Monitoring (EM) and the importance of trending
    • Premises including cleaning and disinfection
    • Equipment and utilities including water systems

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 our 2-day Sterile Products course from Reviews.io

Find out about our course ranges

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Annex 1 2022 Section 10: Quality Control (QC)

This final article looks at the new requirements in section 10 on Quality Control. It is also a useful point at which to reflect on the 2022 version of annex and what might it mean.

Annex 1 2022 Section 9: Environmental and Process Monitoring

This article is covering section 9 which describes the annex 1 guidance for Environmental and Process Monitoring. Section 9 is now a centralized location for monitoring activities.

Annex 1 2022 Section 8: Production and Specific Technologies – part 3

In this final part of the article on section 8 we will look at Sterilization processes. The selection of a sterilization process should be based on scientific principles.

Annex 1 2022 Section 8: Production and Specific Technologies – part 2

This is the second part of the article covering section 8 of Annex 1 2022 and here we are looking at the requirements around Form fill seal and Blow fill seal.

Annex 1 2022 Section 8: Production and Specific Technologies – part 1

This next article in our series is about section 8, which is the largest section of Annex 1 and covers production and specific technologies

Annex 1 2022 Section 7: Personnel

In this article, we move onto the personnel section, section 7.

Annex 1 2022 Section 6: Utilities

In this article we expand upon the equipment section but looking at Utilities as described in section 6.

Annex 1 2022 Section 5: Equipment

In this article we look at the general requirements for the equipment used in the manufacturing of sterile products.

GMP News and Articles

Read our articles on  GMP regulatory developments as well as news about our GMP training courses.

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.

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Most of our public courses are currently 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. In 2022 we began to once again offer traditional classroom courses - see details on each course page.

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Sterile Products

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