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:

All Dates:

The cost is £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 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:

£1300  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

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Why choose Inspired Pharma?

Expert Tutors

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.

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