The Curriculum Vitae of Robert D McDowall.
Date of Birth:
6th September 1950
Visiting Senior Fellow, Department of Chemistry, University of Surrey
|1993 to date||
Principal, McDowall Consulting
|1998 to date||
Director, R.D.McDowall Limited
|1998 to date||
Advisor Cap Gemini Consulting
|1993 to date||
Advisor, PriceWaterhouseCoopers Management Consultancy Services
|1993 - 1989||
Bioanalytical Unit Head, Department of Bioanalytical Sciences, Wellcome Research Laboratories
|1978 - 1988||
Senior Analyst Department of Drug Analysis Smith Kline and French Research
|1972 - 1978||
Research Assistant Department of Forensic Medicine, London Hospital Medical College
Seven years experience as a consultant covering the following areas:
Member of the team to facilitate the development of a corporate validation policy across the site for GMP, GLP and GCP. Writing of the validation policy and the accompanying handbook. Responsible for an audit of the toxicology system and the team responsible for developing it and making recommendations for change to comply with the corporate computing validation policy. Technology transfer of validation skills to toxicology staff to help validate 25 different computerised systems. Personally developed a chromatography validation protocol across for five different functional areas on the site.
Devised and wrote the corporate validation policy for computer systems and a handbook to outline the how to validate a computerised system. Developed templates for all stages of computer validation, together with the training material for the roll out of the computer validation policy.
Reviewed and revised the computerised system validation policy and updated the document to take account of new regulations such as electronic records and electronic signatures.
Provided computerised system validation guidance input to a project for implementing a new IT infrastructure based on Windows NT 3.51; the final network will have 300 workstations. Tasks involved include writing the qualification plan, training and advising both the IT group and the engineering migration team about compliance, interpretation of regulations for computer related systems, assessing the GXP relevance of applications, developing templates for tests, review of documents from the engineering team for compliance and correctness. Vendor audit of the engineering and operation company. Writing phase summary reports and the validation summary reports of each phase of the migration.
Incorporation of the learning points into an updated project based on Windows NT4 to roll out a qualified and validation ready network to 4000 workstations on one site and then throughout the global organisation. Writing of generic qualification documents for successive phases of the project. Provision of advice on change control and configuration management for cost-effective operation of the network.
Two-year contract with the Corporate Year 2000 Project Office for devising the test policy and generic scripts for the testing of equipment and systems throughout the corporation. Then rolling out the policy throughout the Corporation and helping Year 2000 site coordinators plan testing their critical equipment and systems.
Wrote specific test plans written for Year 2000 testing of LIMS, chromatography data systems, computerised analytical systems, building automation systems, clinical diagnostic testing equipment and medical devices. Trouble shooting of a site’s specific Year 2000 problems including telephone systems and network components.
Devised the validation strategy for the rollout of SAP R/3 as part of a project to replace the current MRP system. Wrote the validation plan containing the strategy, worked with the project team to identify the functions and processes to test and qualify as part of the GMP part of the project. Wrote the OQ and PQ test plans and trained the project staff to write the test scripts.
Review of the draft computer validation and electronic records and electronic signature corporate policies. Report written indicating the areas to be enhanced and suggesting directions for development of the policies.
Led and trained the analytical staff to validate a triple quadrupole mass spectrometer liquid chromatography detector by using a hands-on approach. Work passed an external quality audit with no adverse comments and praise of its logical approach to the problem.
Lead discussions with the members of the Analytical Sciences Department for the development of a LIMS strategy for the group and functions that the system should and should not undertake. Advised on the overall approach that the project should take and suggested ways that the time scale could be reduced to save time and overall cost.
Prepared a report on the current status of laboratory automation standards. Facilitated a workshop to develop an international strategy for laboratory automation across all sites within the organisation as part of an overall strategy for Preclinical Research. Further work with the UK subsidiary company to improve efficiency and integration of its operation with the rest of the organisation.
Led an internal team to develop an information technology strategy for the Preclinical Research Division. The scope of work covered the Toxicology, Pathology, Drug Metabolism and Bioanalysis areas intended to formulate the purchase and development of systems over a three to five year time scale.
Led a team to re-engineer the chromatographic data handling in the Pharmacokinetics Department. Preliminary report produced for management approval highlighting advantages and cost savings of the approach (10% of resource saved). Provided expert advice and run workshops to specify a LIMS chromatography data system for the Drug Analysis Department.
Advice and direction at the start of their LIMS project: commercial or in-house system, time scales, automation strategy, what to automate etc. Audit of the selected LIMS vendor and preparation of a report for the project.
Devised a complete validation package for chromatography data systems operating in a regulated environment. Package rolled out to three departments for a variety of data systems. Revalidation of one data system following upgrade for Year 2000 compliance reasons with data migration
Expert advice and input for the Analytical and Clinical Departments into the development of an overall IT strategy for Research and Development.
Devised and delivered short courses for bioanalytical method validation, sample preparation and LIMS for the members of the Bioanalytical Services and Laboratory Services departments.
Member of a team involved in the redesign and re-engineering of a global pharmaceutical and analytical development department based in Switzerland, UK, US and Japan with 450 staff with the aim of releasing more staff for innovation. Involved in interviewing staff at all levels in the company to find opinions of the service offered by the Department and suggestions for improvement. Facilitated the process improvement teams in process mapping and solution development. Identified areas for improvement and co-wrote the report for management approval that scoped the second phase of the project. Worked with the improvement teams on two second stage projects: clinical trials supply and analytical services.
Presented a one-day seminar on LIMS for three analytical development laboratories to present an overview of a system and the options possible from a system. Review and critical appraisal of the user requirements specification for the LIMS and discussions with the project team on the future direction of the project and review of the project plan.
Initial presentation and management workshop for a LIMS to automate bioanalytical and pharmacokinetic studies followed by advice about possible LIMS vendors that could provide a solution. Technology transfer to help write the user requirements specification based on process mapping and critical review of the document. Wrote the validation plan for the system and provided detailed advice for the validation of the system. Review of the selected vendors documentation and practices and response against the user requirements and provided as report of the same. Presentation about maintaining the system in a compliant state when operational.
Validation of a variety of software applications: pharmacokinetics software, chromatography data system and an automated multi-bath dissolution system software.
Responsible for a Year 2000 testing team of 6 staff responsible for the testing of Research and Development laboratory and process equipment and software applications.
Validation of a variety of commercial chromatography data systems in either research and development and manufacturing for a number of multinational pharmaceutical companies.
Prepared a report on the current status of laboratory automation standards. Facilitated a workshop to develop an international strategy for laboratory automation across all sites within the organisation as part of an overall strategy for Preclinical Research. Further work undertaken with the UK subsidiary company to improve efficiency internally and to integrate its operation with the rest of the organisation.
Member of a team for the retrospective validation of a chromatography data system network. Work involved a gap and plan report, workflow mapping current working practices, writing the validation plan, test plan, test scripts and executing the work. Summary of the validation effort in a report and implementing measures to ensure continued operation of the system in compliance with applicable regulations.
Member of the team to re-engineer the drug safety function from drug development to post marketing surveillance. This work involved mapping the current and vision process models, then identifying and defining projects to allow the transfer to the new ways of working. An external expert from WHO, based in Uppsala, Sweden, confirmed the vision model. To enable the client to be more proactive, pharmacoepidemeology and pharmacovigalence were adopted in the improvement programme. Further work on this project has involved collating global requirements for a single drug safety database system.
Devised the principles and wrote a report for a bioanalytical strategy for multi-centre multinational clinical trials. This work integrated the central Clinical Research and Bioanalytical Departments with the Local Operating Companies with specific roles and responsibilities for all personnel defined.
Responsible for writing the SOPs for the operation of a clinical research computer system in the Department of Biostatistics and Data Management and facilitated two workshops to plan the validation of systems within the department.
The input of expert advice from a pharmaceutical industry and validation perspective to a project converting clinical data and records held in six different systems into a single global clinical trials system. Development of compliance procedures for the detailed conversion work.
Input of expert advice concerning the possible use of a laboratory information management system (LIMS) for the management of a phase I volunteer panel and collection of clinical data and measurements from laboratories and at the bedside during clinical studies.
Consultant for the retrospective validation of a clinical data management system operated in a Department of Biostatistics and Data Management. Wrote the validation plan, test plan and test scripts for execution by the staff of the Department, followed by the review of the completed test scripts and collation of historical information for the validation summary report. Advised on a change control process for the system to maintain the validation status.
Consultancy for Year 2000 testing of the system: devised the test strategy for the system and the database listing, checks and derivation rules, wrote the test scripts for execution by the staff and prepared the summary report.
Further work to write the periodic review SOP and to prepare the system and people for an internal corporate audit.
Validation of an object oriented application for derivation rule checking: writing the validation plan and test plan for the application, reviewing documentation produced by the project team and writing the validation report.
Audit of the computerised systems and procedures used within the Department of Data Management for compliance with GCP and GMP regulations and preparation of the report detailing the deficiencies observed together with the regulatory risks associated with recommendations for correction.
Compliance input to the follow up phases to investigate the extent of the problems, preparation of summary reports on compliance issues for the computer systems used in six drug development projects. Audit of the Information Technology Department to assure the quality of the outsourcing service and compliance, preparation of the report with recommendations.
Provided consultancy and training to staff to validate a clinical drug safety system operated in two sites. Wrote the validation and test plans and test scripts for the system, reviewed the completed work and drafted the validation summary report.
Developed a laboratory automation strategy for the Department of Clinical Immunology covering five years. Groundwork was based on mapping of the current processes, identification of the bottlenecks, listing of current skills and the vision of what the department's new processes would become. New analytical techniques and automation approaches were assessed for feasibility and practicability for cost-effective and beneficial implementation. The strategy was developed with action plans for the first 18 months with individuals responsible for monitoring developments in automation and analytical techniques.
Mapped the scope and functions of the current in-house developed clinical data management system for the Data Management Department. Investigated the possible options for implementation of a new system either purchased or developed in-house.
Planned and delivered a two-day interactive workshop for auditing computerised systems used in Clinical R&D. Topics covered were analysis of the regulations and warning letters, system development life cycle, vendor audits, impact of 21 CFR 11, medical device GMPs, discussion on computerised systems used in Clinical R&D. Throughout the workshop, an audit checklist was developed and this was tested during a mock audit of a drug safety system.
Lead discussions with the management of the Analytical Sciences Department about the development of a LIMS strategy and functions that the system should and should not undertake. Further work awaiting project funding.
Validated several chromatography data systems and a microbiology analyser prior to a pre-approval inspection by the FDA. Trained staff in structured approaches to computer validation.
Lead input into a management workshop to generate the overall vision of a LIMS for the both the chemical and pharmaceutical (primary and secondary manufacturing) laboratories of the manufacturing operation. Facilitated the complete re-engineering of the analytical laboratory workflows prior to implementing the LIMS and writing of the requirements specification. Emphasis in the design was on paperless operation, integration with the manufacturing resource planning system, and automatic validation and release of product.
Approval of the short list of vendors for the system and undertook an independent review of each system. Use of personal contacts to find users of these systems to find out weaknesses and strengths of each system. Preparation of a report summarising the overall conclusions.
Prepared and delivered a workshop on computer validation for staff involved in a LIMS project for manufacturing quality control and quality assurance. Review of the functional specification for the overall LIMS.
Post implementation audit of three computerised systems in manufacturing (LIMS, SCADA and DCS) for compliance to European and US regulations for computerised systems and 21 CFR 11. Preparation of a report with recommendations for further action.
Qualified the analytical equipment and computerised analytical systems in the Quality Control Department. Project scope consisted of writing the validation plan, developing test scripts for qualification of specific equipment and instruments and validation of the chromatography data system, execution of the work and writing that validation summary report.
Co-wrote the standard operating procedure and test scripts for the qualification of modular and integrated HPLC systems in analytical development, quality control and bioanalytical services departments. Trained staff members in instrument qualification. Executed the qualification and wrote the validation summary report.
Follow up work consisted of running an equipment qualification workshop, review of current SOPs and writing a design qualification specification for HPLC equipment.
Ran a one-day equipment qualification workshop for the members of the Analytical Chemistry Department covering the rationale for qualification, the regulations for qualification and workshops to develop requirements for HPLC and dissolution equipment.
Advised on the qualification of a customised dissolution robot including a vendor audit, writing and review of the user requirements specification. Wrote test scripts for qualification of specific functions and a holistic test script for the overall system.
Co-wrote the test scripts for the qualification of HPLC systems, dissolution systems and UV spectrometers. Co-wrote the validation plan, user requirements specification, operational qualification test plan, 14 test scripts and validation summary report for the qualification of the largest Millennium chromatography data system installation in the UK. Executed the work with colleagues and staff members.
Wrote test scripts for chromatography data systems and chromatography integrators as part of an equipment qualification project.
Working within the Biotechnology Department led the team that wrote the validation master plan, developed test scripts for the staff to execute and trained the staff. In addition, carried out the assessments of the systems for 21 CFR 11 compliance and suggested corrective actions, procedural controls and supplier liaison.
An assessor for UKAS since 1994 and provide a service for auditing forensic toxicology and drug testing laboratories and any other laboratories using information technology and computer systems.
Audit of two contract research organisations for progress towards Year 2000 compliance and computer validation activities before the selection of one for GLP pre-clinical and clinical studies.
Conducted an audit of the computer department and three systems against GXP regulations for computerised systems. Prepared a report containing observations that highlighted deviations from expected standards and recommendations to correct them.
Audited a contract research organisation that had analysed the client’s bioanalytical study for compliance and quality of work. Trained the analytical staff in bioanalytical approaches to analysis and the difference between that and formulation analysis and outlined ways to audit laboratories when other studies were outsourced.
Audits of LIMS, chromatography data system and other software companies on behalf of clients for quality systems development.
Invited audit of a LIMS installation to assess compliance against current regulations. Wrote a report outlining observations and recommendations to minimise risk.
Audit of two laboratories at different sites for compliance against GMP regulations. Wrote a report with the observations and any recommendations to avoid regulatory action.
Audit of the design, manufacturing and software facilities of an equipment vendor intending to register an instrument as a Class 2 medical device with the FDA. Wrote comprehensive report covering observations against 21CFR 820, draft CDRH guidance to software validation and 21 CFR 11 regulations and made recommendations from changes in management approach, improvement of the software development process, IT infrastructure and the design process.
Repeated the audit a year later covering software development, design records and production. Wrote a detailed report with further recommendations and outlining progress made to date. Follow up work with additional audits on the IT infrastructure and advice on electronic records and qualification scripts.
Audit of the LIMS, SCADA and DCS systems within the manufacturing areas against FDA and EU GMP requirements including 21 CFR 11. Report written detailing observations, non-compliances and suggested corrective actions. Audit was conducted with on the job training of the participating quality assurance staff and system users in regulatory compliance.
Pre-inspection audit of the site’s GLP systems and IT backup. Report written detailing observations, non-compliances and suggested corrective actions. Audit was conducted with on the job training of the participating quality assurance staff and system users in regulatory compliance
Selection and validation of a chromatography data system: planned the validation necessary for the four phases of the roll-out, wrote the URS, validation plan and PQ test plan and trained the users to write the test scripts as part of a technology transfer process.
Wrote a request for information for a LIMS after interview of key customers and analytical staff for a quality control laboratory involved with a chemical development and process scale up. Directive consultancy approach used to select the system on the basis of the culture of the client organisation, analytical requirements and the LIMS companies supplying information. Work done in parallel with developing LIMS requirements for the combinatorial chemistry group of the same organisation. Planned linkage with the MRP and document management projects.
Devised and presented a short course on computerised system validation for the analytical staff of a contract research organisation.
Follow up work involved advice on the design and specification of a LIMS for the whole analytical group. Review of the user requirements specification with comments for the improvement of the document. Further consultancy on the validation of the system.
Consultancy and technology transfer to the analytical staff concerning the validation of mass spectrometer software in a Windows NT environment for a bioanalytical department. Data migration and system retirement issues identified from the existing Macintosh environment. Wrote the validation plan, user requirements and data migration specification, test plan and some of the test scripts. Test scripts written by the staff were reviewed as part of the technology transfer process. Devised the plan and schedule for execution of the testing effort and reporting the overall migration and validation.
Advised on the validation to the LIMS project to automate the bioanalytical department.
Validation of a LIMS used for clinical chemistry and haematology analysis including review of existing documentation and SOPs with recommendations for corrective actions. Writing the validation plan, PQ test plan, vendor audit questionnaires and carrying out the audit. Technology transfer for writing the PQ test scripts and advice in devising test cases. Writing the validation summary report for quality assurance review and system owner approval.
Follow up work included running a one day course in computerised system validation for QA, IT and users.
Developed and presented a one-day course on writing scientific reports and articles. Follow up included the attendees preparing an abstract for a scientific meeting and the writing of an article for publication in a peer reviewed journal.
Follow up work with a two part expanded writing course for all members of the department and linked with a two part effective presentation skills course.
Three part effective writing course for members of the Quality Operations staff, developing their writing skills and working on the review of a report form for out of specification reports.
Co-developed and presented an internal course on the validation of computers to GXP standards for the training of their consultants.
Devised and delivered a two-day interactive short course on practical aspects of computer validation. Preparation and delivery of three day course on LIMS strategies and implementation.
Developed and delivered a training programme on computer validation for the European marketing and support teams of a worldwide LIMS vendor.
Developed and delivered a one day course on regulatory compliance for analytical equipment and chromatography data systems.
Presentation to the Nordic user group on the computer validation and 21 CFR 11 and along with other internal experts from the company.
Evaluation of the current version of a software application for instrument control and data acquisition against the requirements of 21 CFR 11, followed by the preparation of a report to the client outlining non-compliant areas in the software. Review and comment on the latest version of the functional and design specification of the next version of the product to close the compliance gaps.
Presentation of to the software development group on 21 CFR 11 requirements and implications for their software application. Review and comment on the latest version of the functional and design specification of the next version of the product to close the compliance gaps.
A member of the team working with the analytical staff on an operational review of all work carried out. Interviewed staff to elicit information about improvement opportunities, formulated plans for improvement projects, and conducting benchmarking to aid improvement. Reviewed and challenged improvement projects for feasibility, objectives, stated benefits and time scales. Advised on the LIMS project to improve efficiency of the routine analytical function.
Customised and presented a two day workshop on LIMS to help direct the overall direction of the project for the replacement system. Facilitated the interaction between the users and IT group.
Devised and delivered a one-day short course on the validation of computer systems in the laboratory. Auditing of a chromatography data system for compliance with ISO Guide 25 standards.
Audit of two laboratories against the FDA GLP regulations for their ability to analyse biological samples for the Macrofil project. Preparation of a report with recommendations for further action including the possible options for selection of a laboratory for the project.
Advice to the steering committee about LIMS for a water and environmental control laboratory. Edited the user requirements specification for submission to vendors under the European Community Competition rules. Review and comment on the selection criteria for the preliminary selection. Review and comment on the submitted tenders and short listed submissions and input to the final selection.
One day workshop on LIMS for the project steering committee of the laboratory reviewing the proposed approach, experiences and possible suppliers.
Involved in the review of the existing LIMS operating in a several laboratories of a UK regional water company. Writing a report recommending replacement with a commercial rather than in-house written system. Report written to confirm the selection of the vendor and the final system.
Involvement during implementation to provide LIMS advice about interpretation of UKAS regulations for computerised systems, instrument integration, data migration issues and retirement of the current system.