09.16.14
Katherine Ulman has been with Dow Corning Corp. for more than 38 years and currently is the global regulatory compliance manager for the company’s Healthcare unit. Ulman is a member of the American Chemical Society, the American Association of Pharmaceutical Scientists, Control Release Society and the International Pharmaceutical Excipient Council Americas. She earned her Bachelor of Science degree in chemistry from the South Dakota School of Mines and Technology in 1976.
Jim Curtis, senior specialist, Healthcare Applications Engineering & Technical Service, has worked at Dow Corning for 28 years and has a total of 32 years experience in the medical device field. He is a member of the Society for Biomaterials, an officer in its Biomaterials & Medical Products Commercialization Special Interest Group, and a graduate of Cooper Union in New York, N.Y., where he earned his undergraduate and master’s degrees in engineering.
References
Jim Curtis, senior specialist, Healthcare Applications Engineering & Technical Service, has worked at Dow Corning for 28 years and has a total of 32 years experience in the medical device field. He is a member of the Society for Biomaterials, an officer in its Biomaterials & Medical Products Commercialization Special Interest Group, and a graduate of Cooper Union in New York, N.Y., where he earned his undergraduate and master’s degrees in engineering.
References
- U.S. Food and Drug Administration. About Combination Products. Retrieved from www.fda.gov/CombinationProducts/AboutCombinationProducts/ucm101496.htm
- Ibid
- U.S. Food and Drug Administration. Classification of Products as Drugs and Devices and Additional Product Classification Issues. Retrieved from www.fda.gov/regulatoryinformation/guidances/ucm258946.htm
- U.S. Food and Drug Administration. Background and Definitions, Retrieved from www.fda.gov/safety/recalls/ucm165546.htm; U.S. Food and Drug Administration
- U.S. Food and Drug Administration. Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall—Complaints of Delivery System Tip Separation; Retrieved from www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353900.htm
- International Conference on Harmonization of Technical Requirements For Registration of Pharmaceuticals for Human Use. Guideline for Elemental Impurities Q3D. Retrieved from www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step2b.pdf
- Council of Europe. The European Pharmacopoeia Commission revises its strategy regarding the implementation of Chapter 5.20 “Metal catalyst or Metal reagent residues”. Retrieved from www.edqm.eu/en/The-European-Pharmacopoeia-revises-its-strategy-regarding-implementation-of-chapter-520-Metal-catalysts-or-Metal-reagent-residues-1583.html?mbID=128
- International Conference on Harmonization of Technical Requirements For Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7. Retrieved from www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf