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Good Manufacturing and Good Distribution Practice 2010 Symposium

Why attend?
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. This leading event provides delegates with a greater understanding of their role and the robust practices that must be developed to comply with today's workplace.

Benefits of attending:     

  • gain greater knowledge of the quality issues affecting your organisation
  • develop increased awareness of MHRA expectations
  • recognise commonly seen GMP/GDP deficiencies and learn how to reduce them in your organisation
  • discover what you peers are doing through managed workshops
  • understand the inspection process and how you can use this as best prepare
  • meet the GMP/GDP inspectorate teams and have the opportunity to ask questions on aspects affecting your organisation
  • identify key quality critical areas in your own organisation e.g. technical agreements, training, record keeping, delegation
  • reduce and minimise the risk of counterfeits in your organisation’s supply chain through practical steps
  • receive guidance on changing legislation and increasing complexity in the manufacturing and distribution chain for medicinal products.

Who should attend?
All individuals from 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 (QPs) and Responsible Persons (RPs).

For Good Distribution Practice (GDP) in particular, this will be of interest to delegates who have not attended previous symposia, including senior managers, supervisors and key staff members involved in warehousing and distribution activities.

Further agenda details and timings will be published shortly

GMP Symposium - 26 October 2010
The 2010 MHRA GMP Symposium is your opportunity to learn about the key issues affecting Quality Professionals in today's workplace and participate in formulating risk management strategies to tackle them.

The symposium will be a blend of interactive workshops and presentations including:

Quality Risk Management
• Identifying expected risks
• Appropriate vs. inappropriate application of QRM
• MHRA inspection strategy in relation to QRM
 
Out of specification and out of trend results
• MHRA expectations of how these are investigated and managed
• Inspection findings and consequences of inadequate investigation and action

Investigational Medicinal Products
• Annex 13 update
• GMP/GCP interface - identifying the gaps
• Recent inspection findings

Variations regulation
• Update on the changes and implications
• Changes in GMP inspection strategy and conduct

Key updates and changes
• EU Pharmaceutical Package
• EU GMP guide

Formal Q&A
Inspectors' surgery
• As in previous years there will be an opportunity, to engage the Inspectors in dialogue on your specific issues.

GDP Symposium – 27 October 2010
With changing legislation and increasing complexity in the distribution chain for medicinal products the 2010 MHRA GDP symposium is targeted at providing not just RPs, but also Managers, Supervisors and key warehouse personnel, who may not have attended in previous years, with the information they need to stay ahead.

This year’s symposium will be a blend of interactive workshops, formal presentations and feedback sessions focussed in 2 key areas:

"Back to basics - Inspectors' expectations"
• Highlighting the key areas within the guidelines 
• What does the Inspector expect to see in place during an inspection?
• Typical deficiencies found during inspections

Forthcoming changes
• Supply chain review
• The responsibilities, training and accreditation of an RP
• Anti-counterfeiting measures
• EU Pharmaceutical Package
• EU GDP guide

Additionally, the symposium will include:

Formal Q&A
Inspectors' surgery
• Following on from the successful session held in 2009, once again there will be an opportunity, to engage the Inspectors in dialogue on your specific issues.


Send us your scenarios
Specific content for both the GMP and GDP days is still being developed therefore if you have a particular scenario you would like explored during either symposium please send us the details. Email your scenarios with 'GMP/GDP Scenarios' in the subject line to us at mhraconferences@mhra.gsi.gov.uk

Venue

GMP-GDP Symposium 2010 is being held at:

The Grand Connaught Rooms
61-65 Great Queen Street
London, WC2B 5DB

Venue website: www.grandconnaughtrooms.com
Venue location: www.grandconnaughtrooms.com/location/how-to-find-us

The Grand Connaught Rooms are located in the heart of theatre land and surrounded by the buzz of Covent Garden.
Nearest Underground station: Convent Garden Station (Piccadilly Line) is a short walk from the hotel. The Piccadilly line connects Kings Cross station with London Heathrow Airport, by central London. Heathrow airport is approximately 40 minutes by tube from Covent Garden.

Accommodation

A number of rooms at special discounted rates have been secured at The Hotel Russell (which is the sister hotel to the Grand Connaught Rooms) for GMP/GDP Symposium delegates. Special discounted rooms are subject to limited availability - reservation codes will be given to delegates upon confirmed registration.

Fees and registration

Early Bird Rate (Register on or before 12 July 2010)
One day: £385  
Discounted Rate for both days: £655

Special Offer Rate (Register on or after 13 July 2010)
One day: £485
Discounted Rate for both days: £755

Standard Rate (Register on or after 3 August 2010)
One day: £585
Discounted Rate for both days: £855

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
• Online access to the presentations following the event.

Delegates can choose to attend Day 1, Day 2 or both days according to their roles. Discounts are available for delegates booking for both days.

Registration

To confirm your place immediately, pay by credit card today!

Please click here for online registration - you will require credit card details to complete the registration (you will be taken to a new window)

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

Terms and conditions

1.0 Registering your place
1.1 You must pay your attendance fee when you make your booking. We shall send you a confirmation email of your booking and payment.
1.2 MHRA reserves the right to cancel registrations at any stage which do not meet our registration criteria. Registration criteria, if applicable, will be listed under the ‘Who should attend’ section.
1.3 MHRA reserves the right to refuse any application for registration and to refuse to supply any goods or services to any individual. 
1.4 MHRA cannot confirm your place at the event until payment is received. 
1.5 MHRA may refuse entry to the event for delegates who have not made payment in full. 

2.0 Delegate substitutions and cancellations
2.1 Substitutions are acceptable at any time, at no extra charge but must be sent in advance in writing to mhraconferences@mhra.gsi.gov.uk.
2.2 Notice of cancellation received in writing more than 21 days prior to the event will be issued a refund of their registration fee minus a £50.00 cancellation charge. 
2.3 Cancellations received 21 days or less prior to the event will not receive a refund.

3.0 Programme alterations
3.1 MHRA reserves the right to alter the content and timing of the conference, the identity of the speakers, location and/or the venue.
3.2 MHRA will not be liable for any costs or losses incurred as a result of alterations to the programme.

4.0 Postponement or Cancellation of event by MHRA
4.1 Should the conference be postponed for any reason you will be entitled to receive a full refund in respect of the registration fees unless force majeure applies.
4.2 Should the conference be cancelled for any reason you will be entitled to receive a full refund in respect of the registration fees unless force majeure applies.
4.3 MHRA will not be liable to you for any costs or losses you incur as a result of postponement or cancellation.

5.0 Force Majeure Circumstances
5.1 Should MHRA be unable to perform any obligations under these Terms and Conditions due to causes or circumstances beyond its reasonable control, including but not limited to any Act of God, war or threatened war, terrorism or threatened terrorism, fire, flood, drought, strike, lock out or actions of the venue, MHRA will not be liable to you for any losses or claims arising from this.
5.2 In the event that you are unable to attend the conference due to causes or circumstances beyond your reasonable control, but the MHRA conference remains unaffected, the MHRA will not be liable to you for any costs or losses. These circumstances include but are not limited to any Act of God, war or threatened war, terrorism or threatened terrorism, fire, flood, drought or strike.

Page last modified: 22 June 2010