Huaina Li Ph.D, DABT

Manager of Analytical Technologies in Pharmaceutical R&D at B. Braun Medical Inc. and is a Toxicologist certified by the American Board of Toxicology (DABT).

Topic

Material Biocompatibility Evaluation Considerations for Medical Device and Pharmaceutical Industry

Free Registration

Registration is free but required (max 70 registrants). Parking is free. Light food/snacks are provided. 

Dr. Li has been working at B. Braun Medical Inc since 2006. Prior to B. Braun, Dr. Li was Sr. Scientist at Phage Biotechnology Corp to develop & manufacture recombinant proteins for pharmaceutical clinical trials.
Scientist at Phage Biotechnology Corp to develop & manufacture recombinant proteins for pharmaceutical clinical trials.
Dr. Li has more than 15 years of experiences in sterile parenteral product research & development including small volume parenterals (SVPs)/ therapeutics, large volume parenterals (LVP), nutrition therapy (TPN's, lipid emulsions), drug delivery & manufacturing process and packaging & labeling technologies. Dr. Li had depth experience and expertise in material selection, biocompatibility, extractables/leachables, and safety/toxicological evaluations per requirements of regulatory authorities (FDA, EMA, Health Canada). Dr. Li had proven track record of successfully leading R&D projects through IND, NDA, ANDA, PAS, CBE-30 stages.
Dr. Li earned her Ph.D. degree in Analytical Chemistry from Peking University and conducted her Post-Doc research in Dept. of Physiology and Biophysics at University of California, Irvine, focused on developing tools and novel biochemical assays for cell signaling and signal transduction at the single-cell level.