Life Sciences International Regulatory Compliance Consultant

Technical Consultant #1724


Expertise

Regulatory and Compliance

  • Preparing CE Mark, FDA, Health Canada and international regulatory submissions; technical and design file reviews.
  • Design control, new product development, product classification, quality system design, implementation and maintenance to ISO 9001, ISO 13485 (including CMDCAS requirements) and QSR's (PART 820).
  • GMP and FDA compliance and training - designing and implementing GMP and GLP training and awareness programs with an FDA/MHRA focus. GxP advice, covering both GMP (manufacturing and distribution) and GLP (blood bank and testing/clinical laboratories).
  • Validation of equipment; processes, test methods, facilities, product software, business and systems validation including compliance to Part 11 and electronic records and signatures.
  • Site/Company Representative for regulatory inspections.
  • Risk Management (ISO 14971).
  • Medical device vigilance and reporting systems.
  • EU authorized representative.
  • Regulatory inspection gap analysis.

Auditing

  • Internal and external auditing.
  • Pre audit preparations (FDA, MHRA, notified body), post audit advice and guidance.
  • Supplier approval and audit program implementation and Management.

Quality Assurance

  • Quality system design and implementation to meet the requirements of ISO 15189 - medical laboratories - particular requirements for quality and competence.
  • General QA support/advice on how to meet ISO 9001, 13485, FDA, Health Canada MDR and EU GxP requirements (documentation, change control, validation, CAPA/incident management).
  • Providing a risk based approach to meeting our quality and regulatory needs.
  • Process mapping of quality system and related systems.
  • Developing and reviewing Standard Operating Procedures with regards to GxP covering quality, manufacturing and laboratories.

Experience

Undisclosed Company, Principal Consultant, 2007 - Present

  • Consulting in the Life Science industry (including blood establishments) advising on the best methods in meeting the regulatory requirements of the MHRA, FDA, and Health Canada.
  • Supporting clients by providing a risk based approach in meeting their quality and regulatory needs with clear, straightforward, hands on practical approach, which is cost effective with regards to assisting with the development, approval, manufacture, storage and distribution of their products.
  • Consultancy services range from design, implementation and maintenance of quality management systems, preparation of technical files for regulatory approvals, part-time and interim management support, auditing both internal and external, management reviews and presentations, training and mentoring.

Projects

  • Northern Ireland Blood Transfusion Service: Redevelopment of quality management system due to recent inspection resulting in a category 4 letter issued by MHRA. Responded to MHRA and ensuring an action plan followed prior to further planned inspections by developing/updating and implementing new or existing processes within NIBTS and the training of the new processes.
  • Scottish National Blood Transfusion Service: Preparation of MHRA audits covering their 5 main sites within Scotland, and developing/updating and implementing new or existing processes within SNBTS, including a new validation and recall system.

Undisclosed Company, VP of Quality and Regulatory, 2009 - Present

  • Reporting to the Chief Executive, manage the quality and regulatory activities to ensure compliance relevant to quality system and regulatory requirements for operations and products.
  • Setup of the subcontract manufacturing of company's product and obtaining 510k/CE approval for their vascular bypass and access graft.

Omega Critical Care Limited, Glasgow, U.K., Quality and Regulatory Manager, 2004 - 2007

  • Reporting to the Managing Director, manage the day-to-day activities needed to maintain compliance with all quality system and regulatory requirements for all Omega Critical Care operations and products while preforming as a Management Representative.
  • Development and implementation of a quality system compliant with ISO 9001:2000, ISO 13485:2003 and the U.S. FDA quality system regulations.
  • Development and implementation of internal and external audit program for compliance with ISO 9001/13485, 21 CFR Part 820, GMP and GLP regulatory requirements.
  • Conducting internal and external audits (covering suppliers and subcontractors including the sterilization and testing laboratory sub contractor).
  • Development and implementation of GxP (including GMP, GDP and GLP) processes to comply with ISO, U.K. and U.S.A (FDA) regulatory requirements.
  • Interacting with Regulatory Agencies and notified bodies for the preparation and data collection for all regulatory submissions for new and amended European (CE Marking), U.S. FDA Regulatory (510K, PMA, IDE) and all other relevant countries required by the sales and marketing department.
  • Coordinated all external audits carried out by Omega's notified body, the FDA, UL and various competent authorities.
  • Responsible for several major projects: Obtaining both the CE mark and the 510k approval for all of Omega products (including UL approval for the U.S.), the validation of the catheter and monitor manufacturing processes and test methods, including the design and validation of the new clean room, development of the computer/software validation system and the software validation of the monitor, sterilization validation of catheter and obtaining the Investors In People accreditation.

Mi Services Group Limited, Sunderland, U.K. Senior Consultant, 2003 - 2004

  • Gained exposure to a wide range of areas covering validation, quality and the regulatory environment, specifically in the manufacturing and development areas working as a project manager in the Pharmaceutical, Biological and Medical Device industries: This included working throughout the entire project and program life cycle from developing partnerships with clients, strategy interpretation, project management, risk management and delivery of business solutions.
  • Conducting computer validation assignments for Life-Science companies throughout Europe and the U.S.A.
  • Computerized system validation consultancy in GxP regulated environment.
  • Performing gap analysis assessments and corrective action planning on the validation status and 21 CFR part 11 compliance of computer systems for several different clients.
  • Development and implementation of GxP (including GMP, GDP and GLP) processes to comply with U.K. and U.S.A. (FDA) regulatory requirements.
  • Writing validation life cycle documentation including technical specifications, protocols, plans, reports, maintenance procedures, change control and system configuration documents.
  • Consulting on a range of risk assessment, validation and compliance issues, with particular reference to GMP, GLP and 21 CFR part 11.
  • Delivering training to customers in computer system validation, testing, 21 CFR part 11 interpretation and compliance, GMP (21 CFR Part 210 & 211, 820) and GLP (21 CFR Part 58) requirements.
  • Provide electronic record and E-Signature Consultancy, including predicate rule compliance and reporting of business processes.
  • Project managing to ensure projects are completed in a timely and cost-effective manner to the satisfaction of each customer.
  • Pre and post-sales validation and compliance consultancy (for computer systems and general process equipment validation) to clients.
  • Clients included Cambrex, Ventana Medical, Integra Life Sciences, American Red Cross, Novartis, Optos, and Oracle.

AorTech Europe Limited, QA/RA, Bellshill, Glasgow, U.K., 2000 - 2003

Validation Manager, 2001 - 2003

Quality Assurance Validation Engineer, 2000 - 2001

Ethicon Limited, Edinburgh, U.K. Quality Engineer, 1998 - 1999

Smith & Nephew Medical Limited, Hull, U.K. Senior Development Technologist, 1996 - 1998


Honors & Publications

Credentials

  • Applied Biological Sciences, Glasgow Caledonian University, U.K.

Academic and Professional Affiliations

  • UK Trade and Investment Healthcare Sector Advisory Group
  • Medical Devices in Scotland, Vice Chairman/Director of the Board
  • Medical Device Advisory Board

Education

  • B.Sc. Microbiology/Molecular Biology, (with honors) Glasgow Caledonian University, U.K.
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