Madeleine S. Fairweather Ph.D., MRSB, is a freelance cGMP Course Writer and Presenter. Her background is senior management in Quality Assurance of biological and botanical APIs. She was trained through BARQA (now the RQA), and Pharma Systems International UK Limited, working as a course author and tutor for RQA. She has specialist knowledge of therapeutic antibodies, blood, and plasma, as well as recombinant DNA vaccines, siRNAs and materials requiring special handling gained through 20 years in the industry. She has been involved in sterile manufacture, technology transfer and ongoing auditing of API suppliers which has taken her throughout Europe, USA, Australasia, and Asia. She has successfully ensured the manufacturing quality of active substances as well as final products and investigational medicinal products (IMPs/INDs) as GMP Auditor, having trained as a Pharmaceutical Lead Auditor through JEMO Limited. She and has successfully guided sponsors and suppliers in achieving licenses for global markets. Madeleine also provides specialist advice and expertise on requirements for importation testing.