Good Manufacturing Practice course

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 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:

£595  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 this GMP 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)

Feedback from previous delegates:

“Dominic was outstanding”
Site Head, NOVARTIS

“Excellent materials delivered in a digestable format”
Team Leader, SOURCE BIOSCIENCE

“Great trainer, excellent training, very interesting.  I enjoyed every minute.”
QA Officer, SOURCE BIOSCIENCE

“Super training course. Will definitely keep you in mind for future requirements.”
Business Manager, SMITHERS PIRA

“Thank you for making the training so interesting”
Senior Buyer, INDIVIOR

“Dominic is an excellent tutor – very interesting without being boring”
Laboratory Analyst, DERMAL LABORATORIES

“Excellent – well presented”
Team Leader, TEVA

“Dominic was brilliant – one of the best GMP courses I have attended”
Facilities Manager, DDD Ltd / Fleet Laboratories

“Excellent – truly inspirational”
Project Manager, Concordia

“Brilliant”
Production Technician, Merial Animal Health

“An excellent and relaxed course”
QC Manager, DDD Ltd

“An excellent course”
QA Officer, TEVA

“Very enjoyable”
Engineer, TEVA

“Well presented and interesting”
Director of Clinical Operations, TAKEDA

“Excellent – a very good trainer”
Compliance Specialist, TAKEDA

“Fantastic – kept everyone interested an engaged”
QA Manager, Escubed Pharma

“Very well presented, entertaining and informative”
Production Supervisor, Perrigo

“Very knowledgeable and eye opening”
Team Leader, Aesica

“This is an excellent training course”
QA Audit Manager, Aesica

Dates:

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

Times: 

 09.00 – 16.30.

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 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 contents:

• 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

A short online refresher/compliance programme costing from £95 per delegate is also available with versions for Packaging, Warehouse and Manufacturing personnel available – for more details click here