Web Code: PDAFDAC411
Member/Nonmember Price: $75
During FY 2010, there was an increase in enforcement as a result of manufacturing problems unidentified during international CGMP inspections. This seminar will provide highlights from FDA's international surveillance, review trends, and discuss case studies.
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales
Supply Chain | Clinical Supply Material Preparation | Executive Management
Diane Alexander, Chief, Biological Drug and Device Compliance Branch, CBER, FDA
Ms. Alexander serves as a Supervisory Consumer Safety Officer (CSO) with the Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research. As a Supervisory CSO, Chief, of the Biological Drug and Device Compliance Branch, she is responsible for the review and evaluation of administrative and legal actions for biological drugs and devices regulated by CBER. She began her service with FDA in 1995. Prior to joining FDA, Ms. Alexander pursued a degree in Medical Technology with a specialty in Blood Banking and was employed as a Medical Technologist in the Washington Hospital Center’s Blood Bank. Ms. Alexander received her Bachelor of Science degree in Biology from St. Mary’s College of Maryland.
Carmelo Rosa, Supervisory Consumer Safety Officer, CDER, FDA
Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Mr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. in 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality. Mr. Rosa is also an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives, and is also responsible for the evaluation of all GMP inspection reports of foreign pharmaceutical manufacturers and testing facilities. He is also one of FDA's representatives at PIC/S.
Kimberly Trautman, Expert on Medical Device Quality Systems, CDRH, FDA
Kimberly A. Trautman is FDA’s Expert on Medical Device GMPs and Quality Systems. She was responsible for writing the final Quality System regulation and preamble published in 1996. Ms. Trautman was also responsible for the development and implementation of the extensive Quality System regulation Roll‑Out and training programs. She reviews inspection reports of foreign and domestic medical device manufacturers to identify violations of the Good Manufacturing Practice (GMP) requirements, and provides GMP guidance to FDA field investigators and the medical device industry. Ms. Trautman provides GMP expertise to CDRH for various legal actions and regulatory reviews.
Ms. Trautman was the chair person for the Global Harmonization Task Force (GHTF) ‑ Study Group 3 from 1996 - 2005, and has been a member of GHTF since 1993. Ms. Trautman is a US delegate for ISO/TC210, “Quality Management and Corresponding General Aspect of Medical Devices” Working Group 1 and is the US TAG co-chair for Working Group #1. Ms. Trautman is also a representative to the US TAG to ISO/TC176, “Quality Management and Quality Assurance.”
Ms. Trautman was a member of the Steering Committee for the Center for Drugs “GMPs for the 21st Century Initiative” and was co-chair for one of the Working Groups on Quality Systems. She is also a member of the Combination Productions GMP Working Group.
Ms. Trautman has given lectures at medical device training courses for FDA field investigators, DSMICA GMP workshops, AdvaMed conferences, RAPS conferences, FDLI workshops, ASQ/FDA Biomedical Industry Update Seminars, and many others.
Ms. Trautman received her Bachelor of Science degree in Molecular and Cell Biology from The Pennsylvania State University, University Park, Pennsylvania, and a Masters of Science degree in Biomedical Engineering from The University of Virginia, Charlottesville, Virginia.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093