Quality Assurance Consultant

Dr Madeleine Fairweather

Audits, remediation, QMS planning and change, in-house training, and a personnel systems management advisor. EU and UK GMP GLP GCP FDA 21 CFR Parts 11, 50, 54, 56, 210, 211, 312 ICH Q7A, E2A, E6 

Education: Honors Degree in Botany with Microbiology (Reading University, 1990) Doctorate in Biochemistry and Molecular Biology (University of Cambridge, 1995) LRQA and IRCA Lead Auditor: Quality management systems: pharmaceutical manufacturing and packaging (ISO 9001, PS 9000) Experience strong biotechnology background in vaccine and anti-toxin manufacture. Twenty-five years in the public and private sectors cGMP Quality Manager (twelve years); novel medicines for FDA, MHRA, EU/EEA, ICH, and TGA-controlled markets Successful Specials License acquisition for the manufacture of novel recombinant DNA-based medicines and antitoxins IMP and API experience APIs are specialists in therapeutic antibodies for fractionation from hyperimmune apheresis plasma. Extensive world-wide travel is required for supply chain verification. Novel drug registrations in UK, USA. Advanced therapy medicines (ATMPs): e.g., rDNA, siRNA Projects: (1) GMP biomanufacturing of recombinant vaccine vectors for anti-tumor therapy (Clinical Study Phase I, Jenner Institute); (2) transdermal patch delivery. (3) anti-toxins; and (4) rDNA antigen vaccines. QMS All quality management system processes and documentation (paper, electronic, hybrid, cloud). FDA, MHRA hosted MHRA and FDA inspectors. All successful first registrations (1) safety pharmacology and toxicology; (2) cGMP manufacturing licenses; and (3) ongoing successful surveillance and reassessment by competent authorities. Training provider: trainer in how to apply quality management systems to maintain organizational success. Bespoke and standard packages are provided. Calibration and Testing: UKAS-accredited test and calibration laboratories; compliance audits

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