Bethesda, Md. – The Parenteral Drug Association (PDA) is proud to announce the confirmation of expert regulatory speakers at this year’s Global Conference on Pharmaceutical Microbiology.
Thomas J. Arista, Investigator, National Expert, Pharmaceutical/Biotechnology, ORA/ORO, Division of Field Investigations, FDA will discuss Practical Regulatory Guidance on Risk Assessment for Microbial Controlled Issues.
The agenda includes discussions on topics such as objectionable microorganisms, investigations of microbial data deviations, manufacturing and product attributes impacting sterility assurance, new technologies and more.
A highlighted session at this conference, scheduled for October 25-28, 2010 in Washington, D.C., is Global Regulatory Perspectives on RMM. It will provide an overview on current perspectives and future directions of various regulatory agencies across the globe (FDA/CDER, FDA/CBER, TGA and PDMA) in the area of Rapid Microbiology Methods (RMM) as it applies to product testing and release.
Confirmed speakers include: Vivienne Christ, PhD, Chief Microbiologist, OLSS, Therapeutic Goods Administration, David Hussong, PhD, Director, Microbiology, CDER, FDA, Rajesh Gupta, PhD, Deputy Director, Division of Product Quality, Office of Vaccines Research and Review, CBER, FDA and Tsuguo Sasaki, PhD, GMP Expert, Office of Compliance and Standards, PMDA.
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide.