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.
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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
The cost is £1190 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.
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.
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 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
£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.
A 2 day course with start times as follows:
Day 1: 09.00 – 16.30
Day 2: 09.00 – 16.00
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]
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.
Why choose Inspired Pharma?
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 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.
A superb course
Very good, informative and well presented
A very good overview
Delivered well – information very relevant to my role
Recent independently verified reviews about this course from Review.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.
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Online courses available anytime anywhere
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.