(WINTER 2010)

Expand your knowledge on how to ensure compliance of your firm to the FDA regulatory standards. This course will enable you to increase your understanding of medical device and pharmaceutical product compliance activities within your organization and the industry in general. Through a case study approach, this course analyzes the different types of FDA regulatory sanctions with emphasis on FDA 483, and Warning letters. Through this case study approach students will also learn the method and mannerism of response to the FDA 483, Warning letters as well as the development of corrective actions. An emphasis is also placed on the common industry compliance activities such as preparing for an FDA inspection (CGMP, PAI), hosting, and interaction. See enrollment confirmation for login information.

Tarra S. Roshan, B.S., MBA, is a Corporate Technical Services / Quality Systems Sr. Specialist at B.Braun Medical, Inc. Ms. Roshan has a BS degree with a minor in Microbiology and an MBA with emphasis in Management and Leadership. Ms. Roshan has over 14 years of industry experience in the areas of Biotechnology, Medical Device, and Pharmaceuticals (solid oral dosage and IV solutions). Ms. Roshan' s areas of expertise include but are not limited to FDA 21 CFR for the Pharmaceutical, Device, and Biotechnology industries as well as ISO 13485:2003, ICH guidelines, EU Clinical and Medical Device directives, and PDMA. She created and implemented numerous FDA & ISO mandated quality systems within these industries. She has held numerous training events in areas of FDA & ISO expectation with regards to interaction, communication, and quality system requirements. She has hosted numerous FDA (Federal and State), ISO, and international regulatory audits including communications and correspondences with these agencies. MS. Roshan was also a 3 year program Director at the PDA, Southern California Chapter and was the recipient of the 2004 chapter volunteer award.