Sterile Products course

Sterile Products 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.

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 location:

UK courses (Reading, Berkshire)
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.

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.

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.

To book a place on the Sterile Products course please use the online booking system by selecting the ‘Book Now’ button on the event of your choice (at the top of the screen/page)

Previous feedback:

“A superb course”
QA Officer, PHE

“Excellent – tutor kept us interested”
Microbiologist, Morefields Pharmaceuticals

“I recommend this course”
Microbiologist, Morefields Pharmaceuticals

“Informative and enjoyable”
Operator, MOREFIELDS PHARMACEUTICALS

“A very good overview”
Production Scientist, PHE

“Excellent”
QA Officer, PHE

“Very good, informative and well presented”
Operator, TEVA RUNCORN

“Delivered well – information very relevant to my role”
Operator, TEVA RUNCORN

Dates:

See top of this page for current public dates. Also available for in-house delivery, and may be customised if required.

Times:

A 2 day course with start times as follows:

Day 1:  09.00 – 16.30         Day 2:  09.00 – 16.00

Tutors:

Dominic Parry

Dominic Parry has worked in the pharmaceutical industry since 1992, and is a leading pharmaceutical quality management specialist. He worked for 4 years at Evans Medical Limited (now Novartis Vaccines) as a Production Development Scientist. He then moved to Hoechst Marion Roussel (now Patheon, UK), where he worked for 4 years as a Quality Assurance Officer and then Validation Manager for the sterile manufacturing operations.Over the past 15 years he has worked as a leading pharmaceutical GMP trainer and Quality Management System specialist. He works closely with pharmaceutical companies and their suppliers on evaluating, developing and continually improving their quality systems.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. He is Managing Director of Inspired Pharma Training Ltd.

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 to RSSL as Pharmaceutical Training Centre Manager and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  In 2012 he started as a freelance consultant specialising in Microbiology and Quality Systems

Course contents:

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