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 - 19th October 2010
This intensive one day course is intended to evaluate Good Distribution Practices (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C 63/03 and the new requirements included in the 2007 Orange Guide. It offers a practical explanation of the guidelines for those who are active in the field of setting up and implementing GDP, as well as the management of quality systems for pharmaceutical products. The course is aimed at any company that has, or is, considering obtaining an MHRA Wholesale Dealer’s Licence/EU Licence, Wholesalers/Distributors, Manufacturers, Pharmaceutical Suppliers and Service/Transport providers. It reviews GMP/GDP supply chain integrity and examines the risk of counterfeit pharmaceutical products, a growing concern today. The course also reviews sample deficiencies found by regulators and how to improve compliance in these critical areas.
Dates - 8th - 9th September 2010, 2nd - 3rd November 2010
PROGRAMME INCLUDES SPEAKERS FROM MHRA - YOUR CHANCE TO UNDERSTAND CURRENT REGULATORY EXPECTATIONS!
This intensive 2-day course evaluates the key roles and responsibilities of the Responsible Person & Deputy RP (RP) in relation to Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C 63/03, and the new requirements included in the MHRA 2007 Orange Guide.
Fully reviewing Good Distribution Practice (GDP) as required by Licence Holders, it provides an understanding of the key GDP Quality Systems required to operate and fully meet regulatory requirements.
Dates - 13th - 14th July 2010, 12th - 13th October 2010
This highly interactive and practical training course is aimed at those people working in the pharmaceutical industry who are about to start auditing or those who already
audit but have no formal training. It provides an introduction to the guideline for Quality Management Systems auditing specified in the international standard 19011:2002. Delegates will learn and then practice how to plan, execute, report and close-out internal audits as well as write non-conformity reports linked to a GMP clause. The course focuses on EU GMP as an audit standard but the auditing techniques described are applicable to others standards applied including CFR21 210 and 211; a range of other standards appropriate to the pharmaceutical industry (PS 9000, GDP, ISO 9001) are described briefly but not explored. The course will be assessed and certified by RSSL in line with the requirements of its Lead Auditor course, which is certified by IRCA.
Dates - 21st - 22nd September 2010
It is a regulatory requirement for organisations to audit API manufacturers, suppliers of key excipients & packaging materials and contracted out laboratory services. This course covers the skills and processes necessary to perform effective external audits and follows the processes described in ISO 19011 - the international standard for auditing. Specifically the course focuses on the standards used by external suppliers to the pharmaceutical industry – EU GMP Part II, PS9000 and 9100, GCLP and ISO 17025. Several elements of Quality Management Systems (ISO 9001) are explored in detail which helps build knowledge and confidence in this universally recognised standard on which many of the above are based. The course is suitable for people who have already undertaken some auditing (usually internal auditing) and who are now wishing or being required to perform external audits; it is also useful for QPs and managers who are concerned with supplier auditing. Delegates will learn and practice how to plan, execute, report and close-out external audits including writing non-conformity reports.
Dates - 29th November - 3rd December
Location - Oxford
Successful completion of this intensive five day course provides the delegate with a qualification in auditing that is recognised by the International Register of Certified Auditors and the Pharmaceutical Quality Group. The course is focused on ISO9001 and the specific GMP standards that have been developed for the supply of packaging and excipient materials to the pharmaceutical industry. ISO9001 is covered in detail and this will enable pharmaceutical auditors to converse in the language that is universally used by its suppliers. It has had continuous IRCA accreditation since its establishment in 1999 and has a very high success rate. The course is aimed at QA, QC and purchasing professionals from pharmaceutical companies, suppliers and third party certification bodies. It is also highly recommended for Qualified Persons as part of their continuous professional development and is suitable for people who have been doing some auditing already (perhaps internal auditing and/or supported external audits) who have now been asked to take the lead in external supplier audits.