Biography
Rama K Pidaparti has over 25 years of industry experience. He has a M.S in computer science and Healthcare and Life Sciences courses from Sloan School of Management. He has worked on regulatory compliance aspects from concept to post market, at multiple Life Sciences businesses such as GE Health care, Boston Scientific, Medtronic, Zimmer, Johnson and Johnson, Genzyme, Genentec, Millennium Pharmaceuticals. He is a seasoned speaker on Compliance related topics at Life Sciences events.
Research Interest
Advisory Management Consultant in the IT, SCM, R&D, QA-RA & Compliance space for the LifeSciences & HealthCare sector
Biography
Daniele Rubert Nogueira is a postdoctoral researcher at Federal University of Santa Maria (Brazil). She received her Master degree in Drug Quality Control from Federal University of Santa Maria (Brazil) in 2009 and then the Ph.D. degree in Pharmaceutical Sciences from University of Barcelona (Spain) in 2013.
Research Interest
Her research focuses on in vitro toxicology, nanotechnology, drug quality control and validation of analytical methods. She has published more than 35 papers in reputed journals.
Biography
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third party contract-manufacturing representatives. Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
Research Interest
Kenneth Christie responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.