Good Distribution Practice course

Course overview:

Delegates will learn about GDP and how it is applied during warehousing and transportation of pharmaceutical products.  Delegates will leave the course with a clear understanding of the requirements of EU GDP and how it is used.

Who will the course benefit?

This GDP course is aimed principally at personnel new to working with GDP as well as those needing an update on more recent changes in GDP requirements and expectations.  The course is also of great value to anyone who is, or wishes to be, a Responsible Person (RP).  In addition the course will provide those used to working with Good Manufacturing Practice (GMP) an insight into the principle similarities and differences between GDP and GMP.

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:

£1195  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 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)

We also have available a one hour online course costing £95 – find more details here.

Feedback from previous delegates:

“Very interactive”
QA Officer, Sanofi

“Good content, nice pace & well delivered”
Compliance Manager, Thornton & Ross

“Excellent”
QA Manager, Sanofi

“Very informative and enjoyable”
QA Manager, Sanofi

“Excellent – informative and interactive”
Logistics Manager, Thornton & Ross

“Well presented and informative”
Senior QA Officer, Thornton & Ross

“Really well presented with a great mix of slides and exercises”
QA Manager, Sanofi

“Very good knowledgeable tutor, enthusistic and approachable”
Supply Logistics Director, GSK

“Great presentation, brilliant knowledge”
Compliance Systems Co-ordinator, GSK

“A very interactive course”
Supply Quality Officer, Wockhardt

“This was a great course that met my needs to get trained in GDP. There were lots of practical examples to test learning during the course”
Director Regulatory & Medical Affairs, Infirst Healthcare

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:

Christine Morris

Christine started her career with Sanofi working in QC over 20 year’s ago, moving through to the QA Department and QP training as her career progressed, finally working as Head of Quality.  She has experience of working in both ethical and generic pharmaceutical companies and with a wide range of dosage forms.  She is eligible to work both as a Qualified Person (QP) and a Responsible Person (RP), having extensive GMP and GDP experience internationally

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.

Course contents:

• An introduction to GDP
• The similarities and differences between GMP and GDP
• Why do we have GMP and GDP in pharmaceuticals?
• Licences for medicines and enforcement
• The legal status of GDP
• The structure of the EU Guide to GDP
• Current and future issues in GMP
• The Falsified Medicines Directive (an overview)
• Duties of Management and the Responsible Person
• The principle GMP requirements for documentation and records
• GDP in the warehouse
• GDP during transportation
• The recall mechanism

The course contents above reflect our popular one-day course format and these will be updated shortly with the contents of the new 2-day course.

We also have available a one-hour online course costing £95 – find more details here.