Delivering safe medications: The importance of cGMP and aspects of FDA inspections – January 28, 2025
January 28, 2025, 2:00pm EST
ABOUT THE WEBINAR
Why Attend?
•Facts to Consider1: Established in 1906, the Center for Drug Evaluation and Research (CDER) annually receives more than 300,000 submissions. This translates into millions of data points reviewed to bring new drugs to market.
• Relatable experience: Gain insights from Dr. Quirk a 2023 ACPHS graduate with a MS in
Pharmaceutical Sciences and a PharmD. Currently a second year biomanufacturing fellow through the College gaining experience at Curia Global and the FDA.
Key Takeaways:
•Summarize the structure of the FDA and its source of authority
•Define cGMP in the context of drug manufacturing facilities
•Review the types of FDA drug manufacturing facility inspections
ABOUT THE SPEAKERS
Mackenzie Quirk is an accomplished professional who is excited to be the first ever Global Biomanufacturing Fellow. Mackenzie holds a Master’s degree in Pharmaceutical Sciences and is pursuing a PharmD from Albany College of Pharmacy & Health Sciences, Albany, NY. She graduated summa cum laude from Siena College, Loudonville, NY, with a Bachelor’s of Science degree in Biology and minors in both Chemistry and Spanish. Her research experience includes a Master’s thesis titled “Assessment of the in vitro Efficacy of 5-Aminolevulinic acid in Combination with Methotrexate: A Potential New Therapy for the Treatment of Psoriasis,” in addition to undergraduate organic chemistry research that has been published in the journal of Bioorganic and Medicinal Chemistry.
Mackenzie has held various leadership roles throughout her academic and professional career, including serving as President of AAPS-ACPHS, the Director of the VIP Case Competition for IPhO-ACPHS, and President of Inspire Autism Awareness Club at Siena College. On weekends and holidays, Mackenzie enjoys working as a Pharmacy Intern at Kelly’s Pharmacy, Greenville, NY.