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Quality Bites 2019
A Digital Compliance Conference

Bringing Together Experts Linked By A Fundamental Quality Risk Management Approach

 

 

Event Overview

In numerous industries, not exclusive to the life sciences environment, we have a function labelled Quality Assurance, Compliance, Audit or some such variation. A function which by definition, is accountable for the assurance of quality in their area of an organization. A true quality infrastructure cannot be aligned to one function and should be the responsibility of every employee, at every level, in every process.

Quality cannot be siloed or cordoned off and the involvement of all roles is itself a gauge of success. Through the Quality Bites Digital Conference we will share with you that assurance of quality risk management is an underlying methodology across numerous like minded companies, inclusive of the entire life-cycle of process improvement which is inherently intertwined with operational work.

Our event takes inspiration from Shark Week, where Discovery focuses content for a week long conversation on matters relevant to the preservation and sharing of knowledge regarding sharks of all shapes and sizes.  During our Quality Bites Digital Conference, we will spend a week together discussing matters relevant to quality, compliance and risk management, unifying experts and professionals from like-minded environments to raise awareness across diverse aspects of the clinical research industry. We can learn so much from each other.  

Working in collaboration with our global colleagues

Thank you to our partners and speakers joining us to speak during this event.

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Live Event Schedule

You can register for any of the sessions below by simply clicking the link. All sessions are free of charge.  After registration, you will receive a unique meeting invitation containing both webinar and audio details. We look forward to you joining the conversation.

Select a date below to view available sessions.

October 21st

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October 22nd

A Life in a Day - a patient centered experience that delivers measurable and qualitative benefit

This dynamic webinar will introduce a unique and visceral experience that has been designed specifically for the healthcare sector to ensure quality of outcome by putting the patient at the heart of operations. Hear Mark Doyle, the innovator and Founder of The Method, talk about the project and it’s impact on quality in the healthcare sector.

Date: October 22nd 8am EST

Length: 60 min

Speaker:  Mark Doyle
Founder of The Method

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Audit/Inspection Readiness - Best practice for the preparation, conduct and close out of an Audit/Inspection

‘Inspection Readiness’ is the status any company should attain in order to be prepared for regulatory authorities and sponsors to inspect processes, systems, documentation and related records. This applies to both inspections and audits with the objective of ensuring compliance with standards expected within the industry to safeguard subject safety and data integrity.

Date: October 22nd 11am EST

Length: 60 min

Speaker: Lyn Hampshire
Training Manager, Pharm-Olam

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Computer Validation 4.0 - Reducing Validation time while increasing Quality

With the increasing demand for computerized systems and clinical cloud based technologies to support the CRO/Sponsor interaction the need to find risk based and collaborative ways to reduce the cost of validation has become critical to rapidly deploying GCP supportive technology. Ensuring the quality of the delivered platforms has become paramount while keeping our data integrous and our patients safe. 

Date: October 22nd 1pm EST

Length: 60 min

Speaker: Stephen R Ferrell
Compliance Path | Managing Director - Americas

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Logical Simplicity, a guide to Practical Process Improvement in 8 Steps

Based on the same foundations as six sigma, this simplified and user friendly problem solving method was developed for use in the US Navy for application to any problem without a clear solution. The method utilizes simple logical tools and statistical analysis to find and fix special problems while determining common causes for process behavior. Discovering solutions and planning implementation is all part of the method you will learn in this brief but powerful webinar.

Date: October 22nd 3pm EST

Length: 60 min

Speaker: Melissa Williamson
Director Compliance, Pharm-Olam

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October 23rd

An Auditor Training Programme built on a Bowtie competency control system - The Academy Overview

Recruiting high calibre auditors in the Pharmaceutical and CRO industry has long proven to be a challenge, partly due to the lack of a recognised career path for this critical role, and partly due to a lack of accessible and standardised training to develop the required competencies. We have addressed this challenge through the development of a risk-based auditor training program which focuses on the long recognised competency requirements of the auditor role.

Date: October 23rd 9am EST

Length: 60 min

Speaker: Lyn Hampshire
Training Manager, Pharm-Olam

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Trust and Transparency: Where Science Meets Technology Meets Regulatory

In an age of heightened awareness of data security and protection among patients and regulators alike, governance over clinical trials and the underlying data calls for a unified strategy, not just ‘checking the box’.  Medidata has created a secure, stable and scalable SDLC environment, robust data governance processes, and an inspection-ready quality management system as critical enablers to the success in clinical trial execution.

Date: October 23rd 11am EST

Length: 45 Mins

Speaker: Ari Feldman
VP, Global Compliance & Strategy, Medidata Solutions

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From Analog to Digital: New Opportunities to Transform Clinical Trials

Going from analog to digital processes has been the most transformative force for improving our world in the last 30 years. In clinical trials, there are still several unrealized opportunities to move from analog to digital approaches, whether it's paper documents at study sites, or CRAs operating as road warriors. In every case, moving to digital formats produces exceptional improvements in cost, quality, data capture and productivity. 

Date: October 23rd 1pm EST

Length: 60 min

Speaker: Bill Cooney
President and CEO | MedPoint Digital Inc

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Getting to the Root Cause and Writing effective CA/PAs

Attend to understand the root cause analysis part of case management. We will review investigations, focusing on various scenarios and cases. Skill in the art of defining root causes will be practiced using examples from real cases. Case management can be very straightforward and be done efficiently and the second chapter of this training provides clarity on how to apply methods and tools to reduce time spent responding to cases while improving the quality of the case narratives.

Date: October 23rd 3pm EST

Length: 60 min

Speaker:Melissa Williamson
Director Compliance, Pharm-Olam

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October 24th

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October 25th