The focus of the training conference will be to review the prevailing trends that affect those working in quality within pharmaceutical and healthcare industries, offering advice, guidance and sharing best practice. The event promises to be excellent value for money, offering high quality training for like-minded quality professionals to network and learn from industry leading experts.
The speakers will cover a wide range of topics across GMP, GCP, GDP, PV and Medical Devices. The line-up includes:
Calvin Johnson - AbbVie UK & Ex-MHRA Senior PV Inspector
Presentation Title: Managing risk in pharmacovigilance: pragmatism vs. burden
Presentation Outline: In 2012 the revised EU pharmacovigilance legislation and guidance came into force. The guidance has been supported by GVP modules. There are currently 12 modules that have been finalised and several have been updated since 2012.
Calvin's presentation explores some of the key objectives of the 2012 legislation and guidance with a focus on managing risk and discusses some areas raising the question whether this manages risk in a proportionate and pragmatic way or creates burden on industry.
Alex Hall - QPQuandary
Presentation Title: Implementation of updated Annex 16
Presentation Outline: Alex’s presentation will look at how the UK pharma industry implemented the updated requirements and obligations of the Qualified Person, since the updated Annex 16 came into force in April 2016.
She will look at what impact this update had on the perception of personal and professional risk associated with being a Qualified Person.
Martin Todman - NPD Consultants Ltd Presentation Title: A Changing Landscape for Medical Devices
Presentation Outline: Prompted by advances in technology and safety issues with marketed products, the regulation of medical devices in the European Union is undergoing a transformation. While the opportunity for medical devices is exciting and will herald significant medical benefits, changes in regulation and required standards have a direct impact on design, development and commercialisation processes.
One essential action for manufacturers is to implement and maintain a quality management system covering the full product life-cycle that reduces risk and maximises returns. Changes to relevant standards and regulations will be discussed along with observations reported by notified bodies and our own experience of effective quality management systems.
David Franks - Quality ContextPresentation Title: A quality approach to managing the inspection process
Presentation Outline: When the inspector calls, there is a tendency to panic, get all hands on deck and quickly try to get everything up to speed in order to get through the audit. Being inspection ready is more than just passing the inspection, it is about the preparation, the execution and the ongoing management.
David’s presentation provides ideas to ensure the process is smooth and efficient to avoid inspection ‘panic mode’ and boost productivity within regulatory compliance.
David Thompson - Clarity CompliancePresentation Title: Computer Systems: Risk or Reward?
Presentation Outline: In today’s environment of ever increasing scrutiny on the compliance of computerised systems in GxP environments, can we fully leverage the use of IT systems as business enablers to fuel the growth our business needs? Do we need to take a wider look at the cost / benefit analysis and also consider the cost / risk aspect of not implementing IT systems in support of growth and reducing risk?
The price per person for the event is £250 + VAT and all proceeds will go to The Children’s Hospital Charity.
Click here to book your place using Eventbrite:
https://www.eventbrite.co.uk/e/quality-fuelling-growth-reducing-risk-tickets-22579753651
For more information:
Visit: www.qualitycontext.com
Email: enquiries@qualitycontext.com
Call: 0114 252 1189
The speakers will cover a wide range of topics across GMP, GCP, GDP, PV and Medical Devices. The line-up includes:
Calvin Johnson - AbbVie UK & Ex-MHRA Senior PV Inspector
Presentation Title: Managing risk in pharmacovigilance: pragmatism vs. burden
Presentation Outline: In 2012 the revised EU pharmacovigilance legislation and guidance came into force. The guidance has been supported by GVP modules. There are currently 12 modules that have been finalised and several have been updated since 2012.
Calvin's presentation explores some of the key objectives of the 2012 legislation and guidance with a focus on managing risk and discusses some areas raising the question whether this manages risk in a proportionate and pragmatic way or creates burden on industry.
Alex Hall - QPQuandary
Presentation Title: Implementation of updated Annex 16
Presentation Outline: Alex’s presentation will look at how the UK pharma industry implemented the updated requirements and obligations of the Qualified Person, since the updated Annex 16 came into force in April 2016.
She will look at what impact this update had on the perception of personal and professional risk associated with being a Qualified Person.
Martin Todman - NPD Consultants Ltd Presentation Title: A Changing Landscape for Medical Devices
Presentation Outline: Prompted by advances in technology and safety issues with marketed products, the regulation of medical devices in the European Union is undergoing a transformation. While the opportunity for medical devices is exciting and will herald significant medical benefits, changes in regulation and required standards have a direct impact on design, development and commercialisation processes.
One essential action for manufacturers is to implement and maintain a quality management system covering the full product life-cycle that reduces risk and maximises returns. Changes to relevant standards and regulations will be discussed along with observations reported by notified bodies and our own experience of effective quality management systems.
David Franks - Quality ContextPresentation Title: A quality approach to managing the inspection process
Presentation Outline: When the inspector calls, there is a tendency to panic, get all hands on deck and quickly try to get everything up to speed in order to get through the audit. Being inspection ready is more than just passing the inspection, it is about the preparation, the execution and the ongoing management.
David’s presentation provides ideas to ensure the process is smooth and efficient to avoid inspection ‘panic mode’ and boost productivity within regulatory compliance.
David Thompson - Clarity CompliancePresentation Title: Computer Systems: Risk or Reward?
Presentation Outline: In today’s environment of ever increasing scrutiny on the compliance of computerised systems in GxP environments, can we fully leverage the use of IT systems as business enablers to fuel the growth our business needs? Do we need to take a wider look at the cost / benefit analysis and also consider the cost / risk aspect of not implementing IT systems in support of growth and reducing risk?
The price per person for the event is £250 + VAT and all proceeds will go to The Children’s Hospital Charity.
Click here to book your place using Eventbrite:
https://www.eventbrite.co.uk/e/quality-fuelling-growth-reducing-risk-tickets-22579753651
For more information:
Visit: www.qualitycontext.com
Email: enquiries@qualitycontext.com
Call: 0114 252 1189
