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.
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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 - 12:30 2 December 2020 & 09:30 - 12:30 3 December
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
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
An Introduction to ‘Host’ facilities for GMP manufacturing and MHRA support
Responsive Regulation
Martine Powell — Senior GMDP Inspector, MHRA
An introduction to manufacturing centres designed to support smaller scale manufacturing for Pharmaceutical companies, as Multi-collaborator facilities.
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
Register
Please check back for registration information.
Photo by Allie on Unsplash