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High Wycombe, Bucks

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I am an independent Risk Management consultant and trainer within the pharmaceutical industry SummaryEditRe-order Computer System Validation Process Improvement Quality Documentation Risks Assessment and Management Training Consultancy Specialties: Consultancy Risk assessment and risk management Risk-based Monitoring Training Facilitation Mentoring ExperienceAdd a positionRe-order section Risk Management Trainer and ConsultantEdit Independant Consultant September 2011 – Present (1 year 9 months) Facilitation of Risk Assessment workshops, consultancy on Risk Management and customised training in Risk Management Principles, Risk Management for Clinical Trials, Risk-based Monitoring and other scenarios as requested. MemberEdit CSV working party 1992 – 2012 (20 years) Co-lead and am now a member of the WP to establish the need for a new guideline on collaboration with Academia Quality Risk managerEdit GlaxoSmithKline February 2009 – September 2011 (2 years 8 months) Quality Risk Manager Quality Risk ManagerEdit GlaxoSmithKline February 2009 – September 2011 (2 years 8 months) Responsible for the delivery of training and awareness sessions to establish risk management as a core discipline within CCSE, particularly with regard to facilitation of effective study level risks assessments Ensuring the risk management activities within CCSE linked effectively with risk management practices across R&D Provide Inspection Readiness support for CCSE by way of training and document reviews. During Regulatory Inspections taking place on UK sites support GQC activities as necessary by ensuring the interviewees and documentation are Inspection Ready Co-Chairmanship of Clinical Research Computer System Validation Working Party to deliver open forum sessions to extend the industry's understanding of current regulatory 'hot topics'. Also Chapter Lead for the Risk Management chapter of the new ARO/Pharma guidance publication Validation ConsultantEdit GlaxoSmithKline September 2001 – February 2009 (7 years 6 months) Consultancy on Quality and CSV issues to projects team, study teams and staff as necessary Training of all levels of staff in Quality and CSV awareness and risks assessment Liaison with CSC, DCS IT and other quality and compliance colleagues, representing business issues Increasing awareness among managers generally of 21 CFR Part 11 and GCP requirements, and the business benefits of quality, system validation and risks management Establishment and maintenance of all the necessary processes and documentation for an effective Quality Governance Framework for GSK's working relationship with TCS in Mumbai Development of risks assessment practices consistent with developing corporate and iPlan standards Development of an eLearning module on Principles of Risks Assessment Establishment and maintenance of system registries for BDS and Clinical communities. Establishment and setting up procedures for regular updates from these registries to GSK Japan and CDM/CSS Combined Mumbai registries Establishment of procedures to review Business Continuity Planning documentation for BDS Community critical business partners Working within DIA, ACDM CR-CSV to advance CSV and Risks assessment understanding across the industry Independent Computer System Validation ConsultantEdit Independant February 2001 – September 2001 (8 months) Setting up all necessary procedures and documentation to ensure regulatory compliance for RDMi Training of all levels of staff in Computer System Validation awareness Increasing awareness among managers generally of 21 CFR Part 11 and GCP requirements, and the business benefits of system validation Training ManagerEdit MediChain May 2000 – February 2001 (10 months) Leading a project to set up a training team and facility from scratch to cover all the necessary technical, training and administrative functions required by the project within a hospital Risk assessment and consequent definition and organisation of the User Acceptance testing necessary to validate this innovative use of US created software utilising a UK drugs database Development of a comprehensive suite of training courses for Doctors, Nurses and Pharmacy staff, in a real time, radio frequency controlled electronic prescribing, point of care and stock control system - first in Europe Management of a team to achieve tight project timelines for course development and presentation Successful completion of the project to train and support the product in use for 3 months, however MediChain failed due to lack of investor funding Research Manager CDM QualityEdit Wyeth-Ayerst March 1998 – May 2000 (2 years 3 months) Management of a team to ensure clinical data quality by :- a) ensuring the validated status of all the clinical database management systems, new and old b) training all staff effectively c) appropriate levels of quality evaluation checking Joint management of a US and European team to validate Oracle Clinical 3.1.1 + in-house applications, including an in-depth understanding of relational database functionality and some understanding of SQL. Production of the full system validation documentation set. Chairmanship of ACDM/PSI Computer System Validation Working Party which successfully produced and published the first regulatory approved guideline on the Validation of Computer Systems in Clinical Research ManagerEdit Pfizer 1996 – 2000 (4 years) ManagerEdit Pfizer 1996 – 2000 (4 years) Team leaderEdit

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