London - Monday 11 Nov - Thursday 14 Nov 2019
Glasgow - Tuesday 26 Nov - Wednesday 27 Nov 2019

Good Manufacturing And Distribution Practice 2019

About

The Good Manufacturing Practice (GMP) event is ideal for pharmaceutical industry professionals in quality control, quality assurance, supply chain and production management, as well as regulatory and compliance specialists involved in the manufacturing of medicines. The GMP event is complemented by the Good Distribution Practice (GDP) event which covers distribution aspects.

The GDP event is suitable for all wholesalers, including those operating from registered pharmacies. The event would benefit managers and key staff members involved in procuring, supplying, exporting, and storing medicines as well as Responsible Persons and Quality personnel.

These events will provide latest information and guidance on changing legislation and increasing complexity in the manufacturing and distribution chain. The symposium will offer a highly interactive ‘hands on’ learning experience, detailed workshop sessions will review actual sample deficiencies found by regulators and explain how to address and improve compliance in these critical areas.

  • Gain greater knowledge of the quality and compliance issues affecting organisations.
  • Have a clear understanding of your key responsibilities and accountabilities as Qualified Person, Head of Production or Responsible Person with a clear focus on the legal and compliance aspects.
  • Gain detailed knowledge on the best in class standards of GMP and GDP and why is it so essential for patient safety.
  • Recognise commonly seen GMP/GDP deficiencies and learn how to improve compliance in your organisation.
  • Be familiar with new GMP and GDP requirements as covered by EU directives/regulations and guidelines.
  • Have a comprehensive understanding of the MHRA expectations and how to address and correct actual deficiencies.
  • An opportunity to share concerns and learn directly from the MHRA.
  • Discover what your peers are doing through managed workshops and network with like-minded professionals.
  • Learn how to apply Quality Risk Management principles across your supply chain and manufacturing processes, allowing you to make best use of your resources.
  • Develop your understanding of the use of control strategies to support a risk-based approach to quality across manufacture of all dosage forms, allowing you to make best use of your resources.
  • Meet the experts: attend surgery sessions with key speakers.

 

Questions For The Panel

Once you have registered, you will have the opportunity to submit pre-event questions to our panel of speakers via the Delegate Area. You will be issued with login details on your registration confirmation email. The team will endeavour to answer as many of these questions as they can at the event.

To submit your questions, please log into the Delegate Area and go to Panel Questions in the menu.


Agenda

Please note the agendas are subject to change.

Glasgow

26 - 27 November 2019 — 09:00 - 17:00

Registration and Refreshments

Welcome & Introduction

Richard Andrews — Unit Manager, Inspectorate Operations, MHRA
Bernadette Wilson — GDP Operations Manager, MHRA

Latest changes within the inspectorate and introduction to the symposium

The UK's exit from the European Union

Richard Andrews — Unit Manager, Inspectorate Operations, MHRA

GDP Deficiency data and Falsified Medicinal products Case Study

Peter Brown — Senior GDP Inspector, MHRA

Refreshments / Networking break and Inspectors Surgery

Security and Stolen medicinal products

Terry Madigan — GDP Inspector, MHRA

Enforcement Group update

Naseem Hudroge — Senior Intelligence Analyst, MHRA
Bruce Figg — Intelligence Analyst, MHRA

Company Structures, Complex business models and the supply chain. Customer and Supplier Qualification.

Peter Coombs — GDP Operations Manager, MHRA
Claire Glenister — GDP Operations Manager, MHRA
Alan Bentley — Senior GDP Inspector, MHRA

Lunch and Inspectors Surgery

Workshop session on the challenges of customer and supplier qualification

Tony Orme — Lead Senior GDP Inspector, MHRA
Bernadette Wilson — GDP Operations Manager, MHRA

The implications for wholesale dealers of the UK's exit from the European Union

Tony Orme — Lead Senior GDP Inspector, MHRA
Cheryl Blake — Senior GDP Inspector, MHRA

Refreshments / Networking break and Inspectors Surgery

The Falsified Medicines Directive

Peter Blundell — Senior GDP Inspector, MHRA

The Quiz

Mariam Naqesh-Bandi — GDP Inspector, MHRA
Emanuela Krasteva — GDP Inspector, MHRA

Closing remarks

Peter Coombs — GDP Operations Manager, MHRA
Claire Glenister — GDP Operations Manager, MHRA

After hours inspectors' surgery

All GDP Inspectors

Registration and Refreshments / Inspectors Surgery

Welcome, Changes to the Inspectorate, introduction to the Symposium and an update on the UK's exit from the EU

Richard Andrews — Unit Manager, Inspectorate Operations, MHRA

Laying the foundations: Basic Principles of Control Strategies

David Churchward — Expert GMP Inspector, MHRA

Refreshments / Networking Break

Losing control: Deficiencies and resulting actions

Ewan Norton — Senior GMDP Inspector, MHRA

Q&As to the MHRA Panel

Graham Carroll — GMDP Operations Manager, MHRA

Lunch / Networking Break

Cross-Contamination Control Strategy

Christine Gray — GMDP Operations Manager, MHRA
Jo Parkin — GMDP Inspector, MHRA
Graeme McKilligan — Senior GMDP Inspector, MHRA

Annex 1 Contamination Control Strategy

Alan Moon — Senior GMDP Inspector, MHRA

Refreshments / Networking Break

Control Strategy Interactive Workshop

Q&As to the MHRA Panel

Closing Address

Richard Andrews — Unit Manager, Inspectorate Operations, MHRA

Inspectors' Surgery

GMDP Inspectors

Calendar Download

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London

Glasgow

Speakers

Register

Unfortunately the limited number of Early Bird tickets that were available have all sold out.

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London

Standard Rate Tickets

£ 595 +VAT


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Glasgow

Standard Rate Tickets

£ 595 +VAT

Delegate Area

Once registered, you can login to either event via the forms below. Please note that if you have registered for the Glasgow event, you must use the Glasgow Event Login form on the right hand side of the screen.

London Event Login

Glasgow Event Login


London Accommodation

Glasgow Accommodation