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OVERVIEW

Please take the time to browse the delegate brochure below which has more details on what is in store for delegates in Brighton, including an exclusive flight on the British Airways i360 for those who register on Tuesday 8th November.

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The 2022 International QA Conference will be geared towards workshop and discussion sessions, where delegates can really network with and learn from one another.

Take an active part in discussions or sit back and listen to what your colleagues have to say. This conference we want delegates to re:connect with the industry and each other.

 

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Programme by day

To view a summary of what is scheduled for each GXP/topic, click here.

Panel discussions

A panel will discuss set topics with delegates, with delegates having the opportunity to ask questions throughout.

Wednesday 9th November:

  • Impact of Covid 19 and Ways of Working with Thana Subramanian, Keith Thornley, Virginie Wieter (IT)
  • Quality Conscience: Do the Right Thing (World Quality Week) 
  • New Regulation Impact on Veterinary Clinical Trials with the Animal & Veterinary Committee 

Thursday 10th November:

  • GLP/GCLP Question Time
  • GCP QA Clinic

Open discussions

These sessions will follow the form of our Member Quality Conversations (formerly Coffee Mornings) and be made up of smaller groups who all join a discussion around given topics.

Wednesday 9th November:;

  • PV Audits/HA Expectations for PV Related to Commercial
  • A Model of Quality – Is there a Usable Framework out there in addition to Standards & Definitions? (GPvP)
  • GLP - Audit Findings and responses
  • Big Data, Digital Transformations and Risk Based Approach for Audits: A Shifting Paradigm (Future of Quality)
  • Experiences of Remote Audits: A Case Study - Lessons Learned (Industry Insight)

Thursday 10th November:

  • Quality Oversight of Collaborator/License Partner Relationships What is Expected (GPvP)
  • Current Best Practices in PV Auditing - How Have Things Changed/Moved on, Any Game Changers? (GPvP)
  • Vendor Management :The Risks and Reward of Getting it Wrong or Right (Future of Quality)
  • Building a QMS From Scratch (Industry Insight)
  • Serious Breaches (GCP)
  • An Insight into and Learnings taken From aRMM Inspections (GPvP)

Workshops

Interactive session where delegates will work on a given scenario/topic in groups and get feedback from moderators.

Wednesday 9th November:

  • KPI's in QA - GLP Committee
  • Fraud: Do You Know What You're Looking For? led by Patricia Henley & Barney Horne (GCP)
  • Data Integrity Risk Assessment - as easy as 1,2,3 led by Peter Connaughton (GLP)

Thursday 10th November:

  • How Remote Working Has Changed with the GLP Committee
  • Description of PV System - Management, Compilation, Oversight, Outsourcing led by Jana Hyankova and the PV Committee
  • Quality on a Shoestring led by Gillian Robson (The Research Practice Group)
  • Roles and Responsibilities of Veterinary GCP in Field and Laboratory Studies led by the Animal & Veterinary Committee

Friday 11th November:

  • Annual Audit Risk Assessment:Universe, Audits, Maintenance - Jana Hyankova - PV Committee

Presentations

Wednesday 9th November:

  • The Future of QEM: Self-Investigating CAPAs (Future of Quality)
  • SALSA (Statistical Assessment Layer for Site Audits) (GCP)
  • ISPE GAMP5 Second Edition and the ISO25010 and ISO 27001 (IT)
  • New Technologies: How Do We Adopt Them Quickly and Easily (IT)
  • Implementing DMAIC Tool of Lean Six Sigma in PV Risk Management Activities Leveraging Automation (GPvP)
  • Trends in PV Inspection Findings and the Challenges of Remote Inspections (GPvP)

Thursday 10th November:

  • When Pharma Incorporates IVDs: A Dynamic Unification (Industry Insight)
  • Developing Quality-United we stand, divided we fall (Future of Quality)
  • Impact of Revised OECD Advisory Document on Quality Assurance and GLP (GLP)
  • Implementing GCLP Compliance for HIV-1 Vaccine Clinical Trials in Africa (GLP)
  • Pharmacovigilance Quality Management System Oversight: Partnering Quality and PV Operations (GPvP)
  • Master Schedule: GLP Compliance Requirements and Business Needs (GLP)
  • QA Inter-Site Collaboration to Optimise QA Resources (GLP)

Friday 11th November:

  • MHRA Update - Stephen Vinter
  • Does our QMS Need ISO 9001? (Future of Quality)
  • Quality Culture - A Foundation of Quality-by-Design (Future of Quality)
  • Data Integrity Compliance Planning (GLP)
  • Quality Culture - More Than Just Behaviours (Personal Skills)
  • Informed Consent: How The Industry Evolves to Improve Patients Rights (GCP)
  • eConsent (GCP)

 

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