+44 1635 866699 [email protected]

Sterile Products course

This 2-day course provides a detailed introduction to sterile product manufacturing
Key InformationWhy Inspired?

A detailed introduction to sterile product manufacturing

Do you need to understand the GMP requirements for sterile products and the areas likely to be looked at during Regulatory Inspection?  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 two-day Sterile Products course and leave with an increased knowledge of the GMP requirements essential for effective performance and decision making.

Use these links to navigate around this page: 

Make a Booking

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

Tuesday 20th to Wednesday 21st November 2018

Venue: Reading, Berkshire UK

Tuesday 18th to Wednesday 19th June 2019

Venue: Reading, Berkshire UK

Tuesday 19th to Wednesday 20th November 2019

Venue: Reading, Berkshire UK

All Dates:

The cost is £1190 plus VAT. Please note that events taking place in 2019 cost £1300 plus VAT. Course will be charged in GB pounds. The cost of accommodation is not included in the course cost. For full details of what is included in the cost see below. To find out more the venue select the link in blue in this sentence.

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.

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 verses 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:

£1190  per delegate plus VAT. Course will be charged in GB pounds.

VAT will not be charged for courses held outside the UK. VAT will be charged for the courses held in the UK, 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 of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.

The cost includes:

  • Refreshments and lunch during the course times.
  • Course folder containing copies of slides and supplementary notes and handouts.
  • Course attendance certificate.

Full tutor support and access during course times.

Times: 

A 2 day course with start times as follows:

Day 1:  09.00 – 16.30

Day 2:  09.00 – 16.00

Venue details

Reading, Berkshire, UK

The Holiday Inn – Reading South, 500 Basingstoke Road, Reading, Berkshire, RG2 0SL, UK. The hotel is very close to Junction 11 of the M4 – 25 miles west of London’s Heathrow Airport.

Telephone: + 44 (0)871 942 9067

e-mail: [email protected]

Web:

http://www.hireadingsouthhotel.co.uk/

A special rate of £121 (including VAT) has been agreed with the hotel (subject to availability). This is for Bed and Breakfast and includes internet access. Quote “Inspired Pharma” when making your booking.

Map

Click on map for larger scale:

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 is generally recognised as one of the leading GMP trainers in the UK and brings an enormous amount of interest, enthusiasm and fun into the training he presents.

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

Recent independently verified reviews about this course from Review.io

Find out about our course ranges

GMP Training

QMS Training

GDP/RP Training

GMP Compliance

QP Training

GDP Compliance

Ensure your team understand the importance of Data Integrity

Now Available - online Data Integrity training for your team Our 20-minute online Data Integrity training course will ensure your entire team understand the importance of Data Integrity and their...

New EU GMP Directive published

The European Union has published its new Directive for pharmaceutical manufacturing sites that is to replace the existing Directive (Directive 2003/94/EC) for human medicines. From having an initial look at the new Directive, here are a few comments.

What Pharma Companies Need to Know about Measuring Instrument Calibration

According to pharmaceutical cGMP (current Good Manufacturing Practice) guidelines, pharma companies need to conduct regular instrument calibration as part of their validation and qualification activities. This article gives an overview of what is involved.

Must, Shall and Should – the use of these words in GMP

What is the difference in meaning between these words in the context of GMP?, In this post I explain, using EU GMP as my point of reference, although as you will find out, there are occasions within EU GMP where the incorrect terms have been used.

Management Review – who, what, where and when?

The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?

Standards to use when auditing suppliers

If you are working to Good Manufacturing Practice (GMP) then you will need to audit many of your suppliers. GMP does not really tell you what pharmaceutical supplier standards you should or could use when auditing your suppliers this post lists of all the key standards to use when auditing suppliers including links to all of the key documents and authorities.

EU GMP Chapter 9: Self-Inspection – time for an update?

In the past few years eight of the nine chapters of EU GMP have been updated. However, Chapter 9 has not been updated at all. This is strange as GMP’s stance on Quality Management System thinking has evolved a lot of the past few years, so surely the requirements for the number one mechanism that you have to evaluate this system should be updated too? Here are my thoughts

Data Integrity – why all the fuss?

The careful and secure control of data and records has become a hot topic at regulatory inspections recently. One reason for this is the increased use of computer systems to hold data in one form or another. Let me give you an example of how keeping data accessible can become problematic with a non-pharmaceutical example from my own childhood.

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.

Quick Links

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

Forthcoming Public Courses

November

13 Internal Auditor
20 Sterile Products
27 Problem Solving

December

03 Pharma GMP Lead Auditor Now Full

January 2019

21 Pharma GMP Lead Auditor

Febuary 2019
12 Data Integrity

All pharma training courses held in Reading UK unless stated otherwise. Click on course name for full details.

For 2019 dates select the green 'See all Courses and Dates' button above or to the left.

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.

Why not subcsribe to our mailing list to try a free Taster  of these courses to see if they are of interest?

Visit our Independent Reviews.io website