What delegates have said of recent courses:
“Made understanding of the Orange Guide the easiest I’ve had, delivering exactly to the target audience which is what was required”
“Best course I have ever attended with the best tutors too - very interesting …...and FUN!”
Dates - 9th May 2012, 7th November 2012
This course examines why we have GMP, its legal status and the key GMP issues surrounding pharmaceutical manufacture such as documentation, training and facilities. An established, popular course aimed at any pharmaceutical professional who wishes to gain a basic knowledge and understanding of Pharmaceutical GMP.
Dates - 17th - 19th April 2012, 20th - 22nd November 2012
This stimulating and intensive course builds on the previous knowledge of delegates
and is a natural extension of the 1 day course. It is primarily aimed at key personnel
working in QA, QC, production, engineering and clinical trials, who wish to have a
broader appreciation of GMP. It covers specific GMPs associated with different dosage forms, key facilities, the MHRA and FDA, incoming materials including control of suppliers of APIs, excipients and packaging materials and also features several real-life case studies.
Dates - 11th October 2012
This course is an adaptation of our standard 1 day GMP course, designed specifically
for laboratory staff who have unique, additional requirements laid out in GMP.
The course concentrates on Chapter 6 (QC and Good Control Laboratory Practice) of
the EU Guide to GMP, and also covers the role of Pharmacopoeias, laboratory
reference standards and calibration in addition to the documentation requirements for laboratories.
Dates - 24th May 2012, 1st November 2012
GMP for Medical Devices is the perfect course for people who are new to the medical device industry, diagnostics or those working in the pharmaceutical industry where medical device regulations are applied - inhalers, pre-filled syringes, infusion bags etc. The course covers the requirements of the Medical Device regulatory standard ISO13485 and the regulatory framework and documentation required to market a medical device. Those attending will get an understanding of the requirements and documentation required to market and maintain compliance for medical devices in the market place.
Dates - 1st - 2nd May 2012, 27th - 28th November 2012
The packing process is a complex series of operations, often performed at high speeds and against tight deadlines. Despite the increased use of many on line detection/rejection systems, the majority of pharmaceutical quality complaints and recalls are packaging related. This course gives a detailed background into the complicated issues associated with pharmaceutical packaging. It examines all of the key stages from artwork design, component suppliers through the packing process to final product release. It identifies major areas of risk and discusses how these can be removed or managed. This popular course is aimed at all personnel involved in any aspect of pharmaceutical packaging, including packing staff at all levels, packaging technologists, engineers, auditors, QC and QA.
Dates - 15th March 2012, 5th July 2012, 18th October 2012
The revision of Chapter 1 [Quality Management] and Chapter 2 [Personnel] of Part I of the EU Guide to GMP to bring it in line with ICH Q10 will mean an increasing regulatory focus on senior management responsibility for quality within an organisation. This stimulating workshop is designed to make delegates think about where such responsibilities lie within their own organisation, and poses the important question of the ‘Cost of Quality’ versus the ‘Cost of Non-Compliance’. Starting with a brief consideration of the key elements of the proposed revisions to the GMPs, the course moves through a series of case study scenarios and the consequent implications. Potentially business critical situations are explored to identify root causes and effective remedial and preventive actions.