Good Manufacturing Practice (GMP) & Good Distribution Practice (GDP) Symposium - 11-12 November 2008

Best practice guidance for Qualified Persons (QPs) and Responsible Persons (RPs)

11 & 12 November 2008
Crowne Plaza, Liverpool

The MHRA is pleased to announce 2 days of events aimed at Qualified Persons, Responsible Persons and all individuals involved in GMP and GDP Inspections.

Delegates can choose to attend Day 1, Day 2 or both days according to their roles.

Day 1 – Good Manufacturing Practice – Best Practice for QPs will highlight the role and requirements of the QP, providing guidance on inspections and common deficiencies within both a domestic and international supply chain. The event will also enable delegates to meet and pose questions to the GMP Inspectorate.

Day 2 – Good Distribution Practice – Best Practice for RPs will focus on the role and requirements of the RP, inform delegates on how to prepare for and participate in an MHRA inspection, learn from common system failings through interactive workshops based around frequently raised deficiencies and understand how the Agencies Risk Based Inspection programme will impact upon the role. The event will also enable delegates to meet and pose questions to the GDP Inspectorate.

Day 1 – Good Manufacturing Practice – Best Practice for QPs

GMP – Best Practice for QPs will focus on providing QPs, Quality Control and Assurance, Regulatory and Compliance staff in manufacturing with an opportunity to meet MHRA Inspectors and gain a greater insight into how to improve their own compliance with MHRA GMP Inspection guidelines.

Presentations will be given which will outline the regulatory requirements including considerations for IMP/API/Starting Materials, explore the responsibilities and obligations of QPs, highlight the pitfalls often encountered by working through an example of 3rd country supply, discuss commonly seen GMP deficiencies and explain the role of the Pharmacovigilance QP.

By attending this seminar you will be able to:

• Understand further the role and obligations of a QP, including those working on a contract basis
• Know the role of the ‘Inspection Action Group’ (IAG) in addressing failure to comply with QP obligations
• Develop your organisation’s GMP processes to enhance compliance
• Identify key quality critical areas in your own organisation e.g. technical agreements, 3rd country supply
• Demonstrate increased awareness of MHRA expectations
• Focus on commonly seen GMP deficiencies and learn how to reduce them in your organisation
• Understand the clear role differences between a GMP QP and a Pharmacovigilance QP

Day 2 – Good Distribution Practice – Best Practice for RPs

Good Distribution Practice – Best Practice for RPs will give guidance of the regulatory requirements and responsibilities for RPs and individuals involved in setting up and implementing GDP as well as managing quality systems.

Through interactive workshops, formal presentations and feedback sessions the role and responsibilities of the RP will be outlined. The impact of the Agencies forthcoming risk based inspection strategy will be explored along with the European Commission’s proposals to combat counterfeit medicines.

By attending this seminar you will be able to:

• Gain greater knowledge the role and responsibilities of a RP, including those working on a contract basis and also those involved in virtual wholesaling
• Know the role of the ‘Inspection Action Group’ (IAG) in addressing failure to comply with RP obligations
• Understand the inspection process and how you can best prepare
• Identify key quality critical areas in your own organisation e.g. technical agreements, training, record keeping, delegation
• Recognise commonly seen GDP deficiencies and learn how to reduce them in your organisation.
• Make practical steps to minimise the risk of counterfeits in your organisation’s supply chain
• Meet the inspectorate teams and have the opportunity to ask questions on aspects of GMP and GDP affecting your organisation.

Ask the Inspectorate

During the two day event, the MHRA aims to provide suitable guidance. In order to help us effectively address the issues affecting your organisation, we would ask if you could submit any specific questions you would like to direct at the Inspectorate team.

Please e-mail your questions to: mhraconferences@mhra.gsi.gov.uk with the subject line "Ask the Inspectorate".

Timings of seminar

Day 1 - Good Manufacturing Practice – Best Practice for QPs begins at 09:30am (registration from 9:00am) and finishes at 5:00pm.

Day 2 - Good Distribution Practice – Best Practice for RPs begins at 09:30am (registration from 9:00am) and finishes at 4:00pm.

Venue

The symposium will be held at the Crowne Plaza Liverpool.

The full address is: Crowne Plaza Liverpool, St Nicholas Place, Princess Dock, Pier Head, Liverpool, L3 1QW.

Map and directions can be downloaded from www.cpliverpool.com.

These events will be of interest to:

All individuals within the Pharmaceutical Industry working in Quality Control and Assurance, Regulatory and Compliance within the manufacturing and distribution of medicines. These events will be of particular interest to Qualified Persons and Responsible Persons.

Conference attendance:

Special Offer Rate (Register on or before 10 Oct 2008)
One day: £445 +VAT
Discounted Rate for both days: £695 +VAT

Standard Rate (Register on or after 11 Oct 2008)
One day: £545 +VAT
Discounted Rate for both days: £795 +VAT

The conference fee includes:

• Attendance to Good Manufacturing Practice – Best Practice for QPs or Good Distribution Practice – Best Practice for RPs or BOTH according to package selected;
• Delegate pack, including conference papers;
• Refreshments throughout the day;
• Buffet lunch.

Registration closes on 3 November 2008.

Accommodation

Unfortunately accommodation in Liverpool is extremely limited at the time of this event. Check availability by using the accommodation search on www.visitliverpool.com

The MHRA are holding a limited number of rooms at the Macdonald Craxton Wood Hotel near Chester at a rate of £80.00 B&B per person, per night. To make a reservation please call the hotel on 0151 347 4013 quoting reference: MHRA101108

The Macdonald Craxton Wood Hotel is approximately 13 miles, 25 mins drive, from the Crowne Plaza conference venue. The full address is Macdonald Hotels Craxton, Parkgate Road, Ledsham, Nr Chester, CH66 9PB and their website is: http://www.macdonaldhotels.co.uk/craxtonwood/

How do I register?

Online
Please use our online Registration form.

Fax or post
Alternatively you can download the PDF Registration form (37Kb) and fax to 020 7084 3522 or post to: MHRA Conference and Education Team, Market Towers - 16th Floor, 1 Nine Elms Lane, Vauxhall SW8 5NQ.

Need more information?
If you have any queries with registering or require further information please e-mail the MHRA event team: mhraconferences@mhra.gsi.gov.uk or telephone on 020 7084 2903.