Good Manufacturing and Distribution Practice 2020 

GDP Monday 30 November & Tuesday 1 December

GMP Wednesday 2 & Thursday 3 December

Photo by John Schnobrich on Unsplash

About

Due to Covid-19 and current guidelines the ‘Good Manufacturing and Distribution Practice' (GMDP) Symposium will be returning later this year in a new virtual format.

The Good Distribution Practice (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.

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. 

These events will provide the latest information and guidance on changing legislation and increasing complexity in the manufacturing and distribution chain.  The symposium will offer a virtual learning experience addressing key topics and compliance trends within both Good Manufacturing and Good Distribution Practice and also allowing for networking between delegates and submission of questions to the inspectors.

  • Gain greater knowledge of the quality and compliance issues affecting organisations.
  • Have a clear understanding of your key responsibilities and accountabilities as a Responsible Person with a clear focus on the legal and compliance aspects and eligibility as set out in guidance note 6.
  • Recognise commonly seen GDP deficiencies and learn how to improve compliance in your organisation.
  • Understand the key challenges of Covid 19 on our work, how we maintained regulatory oversight and ongoing work.
  • Learn further about the work of CMT/IAG.
  • An opportunity to share concerns and learn directly from the MHRA.
  • Learn about key development areas for GMP.
  • Learn about reactive, responsive and innovative GMP regulation.

 


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.

Twitter - #gmdp20

Agenda

Please note the agendas are subject to change.

Good Distribution Practice

10:00 - 13:00 30 November 2020 & 10:00 - 13:00 1 December

Welcome and latest changes within the Inspectorate. Review of the agenda.

Michelle Yeomans — GMDP Unit Manager, MHRA

Review of work conducted during Covid-19 including desktop inspections and surveillance work and any ongoing work

Tanya Giles — Operations Manager and GDP Inspector, MHRA

An overview of our response to COVID, changes to processes and how we have supported industry.

Quality Risk Management and Business Continuity Plans

Bernie Wilson — Operations Manager and GDP Inspector, MHRA

Managing changes and the importance of quality risk management in Good Distribution Practice. How to apply the principles of change control and risk management in your business.

PCL Office Overview

Asif Janjua — Process Licensing Office Manager, MHRA

An overview of the functions of the Process Licensing Office and the support they can provide.

Break and networking

Qualification of suppliers, customers and fraudulent websites

Emanuela Krasteva — GDP Inspector, MHRA

A look into supplier and customer qualifications using online resources.

GDP Deficiency Data

Peter Brown — Senior GDP Inspector, MHRA

Presenting an insight into common deficiencies in GDP.

Weakness in the Supply Chain through diversion / reintroduction of stolen medicines

Grant Powell — Enforcement Team Leader, MHRA

Sourcing medicines for Great Britain from an approved country for import - post EU transition guidance

Tony Orme — Expert GDP Inspector, MHRA

Closing remarks from day one

Michelle Yeomans — GMDP Unit Manager, MHRA

Welcome to day 2 and review of the agenda

Michelle Yeomans — GMDP Unit Manager, MHRA

Commonly asked questions

Cheryl Blake — Senior GDP Inspector, MHRA
Chris Groutides — GDP Inspections Officer, MHRA

Cheryl and Chris discuss some of the most frequently asked questions in relation to licence variations, timings of applications, and transport issues.

Expectations of the Responsible Person

Ghazal Rehman — , MHRA

Becoming an RP: expectations, guide note 6; getting experience, training, discussing with other RPs; Personnel- training; how to manage training; choosing and being a contract RP; developing yourself as an RP.

Break and networking

Look out – views of security from inside industry

Terry Madigan — Senior Inspector, MHRA

Maintaining security standards within the medicine distribution chain is paramount to protecting public safety as well as those associated with the distribution chain. Security covers many aspects, and in this presentation the views of pharmaceutical distributers will be reflected mainly in regard to dealing with theft of medicines.

Catching a cold – Case Study

Peter Brown — Senior GDP Inspector, MHRA

An understanding of unusual sales patterns, using real life examples.

Closing Remarks

Michelle Yeomans — GMDP Unit Manager, MHRA

Good Manufacturing Practice

09:30 - 13:00 2 December 2020 & 09:30 - 13:00 3 December

Welcome and latest changes within the Inspectorate. Review of the agenda

Michelle Yeomans — GMDP Unit Manager, MHRA

Covid-19

Reactive Regulation

Ewan Norton — Senior GMDP Inspector, MHRA

Learn what our experience as a regulator has been during the pandemic.

Deficiency data

Reactive Regulation

Ian White — Senior GMDP Inspector, MHRA

This session will explore the deficiency data across the recent period of predominantly office based inspections in addition to our overall findings. 

Inspection Reliance

Reactive Regulation

David Churchward — Expert GMP Inspector, MHRA

How do we manage overseas without physical inspection? How can we manage approval of new sites in 3rd countries during a period where international travel isn't permitted? This session will explore the oversight mechanisms available and how we can maintain our statutory function. 

Break

ATMP centre of accreditation

Responsive Regulation

Martine Powell — Senior GMDP Inspector, MHRA

An introduction to a new accreditation scheme encompassing GMP and GCP to support manufacture of ATMPs

Compliance management

Responsive Regulation

Norman Gray — Lead Senior GMP Inspector, MHRA

An overview of updates and changes to our approach to managing serious and chronic non-compliance within CMT and IAG.

Q&A Panel session

Lewis Corbett — GMDP Operations Manager, MHRA

Closing remarks from day one

Michelle Yeomans — GMDP Unit Manager, MHRA

Welcome to day 2 and review of the agenda

Michelle Yeomans — GMDP Unit Manager, MHRA

Cannabis based medicinal products

Responsive Regulation

Chris Gray — GMDP Operations Manager, MHRA

Cannabis based medicinal products are a growth area in the UK that challenge established procedures for licence approval. This session will explore this and describe how MHRA are working with our stakeholders to adapt to this emerging market. 

Trends from the innovation office

Innovative Regulation

Rick Parker — Senior GMDP Inspector, MHRA

Learn what our industry stakeholders are bringing to MHRA's Innovation Office for support in getting novel products and processes established and licensed. 

Innovative licensing

Innovative Regulation

Phil Rose — Senior GMDP Inspector, MHRA

What is innovative licensing and how will it bring products to market?

MMD - enabling innovation

Innovative Regulation

Tracy Moore — Expert GMP Inspector, MHRA

Learn how the Medicines and Medical Devices Bill supports innovative medicine delivery including point of care manufacture. 

Break and networking

Tech slot 1 - Facilitating IoT in Pharmaceutical Manufacture

Innovative Regulation

Ian Holloway — Senior GMDP Inspector, MHRA

Guidance on the use of IoT in pharmaceutical manufacture.

Tech slot 2 - Facilitating AI in Pharmaceutical Manufacture

Innovative Regulation

Kevin Bailey — GMDP Inspector, MHRA

Guidance on the use of AI in pharmaceutical manufacture.

Tech slot 3 - Distributed Ledger Technology

Innovative Regulation

Lewis Corbett — GMDP Operations Manager, MHRA

Case studies and controls for manufacturing and distribution.

Q&A Panel session

Graham Carroll — GMDP Operations Manager, MHRA

Closing Remarks

Michelle Yeomans — GMDP Unit Manager, MHRA

Register

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GDP Ticket

£295.00

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GMP Ticket

£295.00

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GDP & GMP combined ticket

£500.00


Photo by Allie on Unsplash

Speakers