Dr Madeleine S. Fairweather Ph.D., MRSB, is a freelance GMP course writer and presenter. Her background experience was gained over 15 years in quality assurance of biological and botanical APIs. She has specialist knowledge of therapeutic antibodies, blood and plasma, as well as recombinant DNA vaccines, siRNAs and materials requiring special handling. She has been involved in technology transfer and ongoing auditing of API suppliers for over ten years which has taken her throughout Europe, to the USA as well as throughout Australasia.
She has successfully ensured the manufacturing quality of active substances as well as final products, and has guided sponsors and suppliers to achieving licenses for global markets. Madeleine also provides specialist advice on importation testing and conducts supplier audits.