Good Manufacturing Practice Training

Delegates will learn about GMP and how it is applied in a manufacturing operation.

Course Overview:

Delegates will learn about GMP and how it is applied in a manufacturing operation. Delegates will leave the GMP course with a clear understanding of the requirements of EU GMP and an appreciation of USA GMP.

Who will the course benefit?

Our GMP course is aimed principally at personnel new to Supervisory and Management roles who need a detailed explanation of GMP, its requirements and how it works. The GMP course will also be of benefit for anyone new to pharmaceuticals who have had no significant GMP training previously.

Course Content:

• An introduction to GMP
• The history of GMP
• Why do we have GMP in pharmaceuticals?
• Licences for medicines and GMP enforcement
• GMP in the Product Lifecycle
• The legal status of GMP
• The structure of the EU Guide to GMP / The UK Orange Guide
• GMP in the USA
• Current and future issues in GMP
• Duties of key personnel and departments
• The role of Production, Quality Control (QC), Quality Assurance (QA) and the Qualified Person (QP)
• The principle GMP requirements for documentation and records
• GMP in the workplace
• GMP and documentation
• People, training and hygiene
• Data integrity
• Dealing with problems and root-cause analysis

Course Tutors:

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 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.

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: reservations-reading@ihg.com
Web: http://www.hireadingsouthhotel.co.uk

Course Cost: £595.00 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 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.

The cost of accommodation is not included in the course cost. If required you should book accommodation yourself directly with the hotel.

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. We accept VISA, MASTERCARD and AMEX. Credit card transactions are subject to a 1.5% handling fee.

To book your place:

Please email to reserve a place or call +44 1635 866699 quoting "Clarity Compliance".