Expertise: Quality Assurance, Standard Operating Procedure, Training, and Inspections

Ms. Milani manages quality systems on all Anapharm sites through a group of experienced auditors who cover clinical, bioanalytical, and scientific activities. The group also closely monitors supporting entities, including information technology, clinical laboratories, training, and any service providers that have a direct impact on Anapharm’s regulated activities. All audits are performed according to the standards of FDA, ICH EMEA, as well as Brazilian GLP, GCP, and GXP. Ms. Milani also manages compliance with Anapharm’s standard operating procedures, and has developed effective quality performance to ensure continual improvement in quality and compliance. She has hosted numerous positive regulatory inspections from FDA, HPFB, European agencies, ANVISA certifications (Brazil), and has participated in many positive GLP/GCP assessments from pharmaceutical companies worldwide. She previously worked for more than 7 years in an environment analysis laboratory, where she contributed to implementing and managing a GLP QA program.