Dr. Suggy Chrai is a senior executive with over 30 years of experience in the pharmaceutical and biotechnology industry. Suggy was Vice President, Delsys Pharmaceutical Corporation, Vice President, The Liposome Company, and Vice President, Mova Pharmaceutical Corporation. He grew through the ranks at Bristol-Myers Squibb. At Schering Plough, he started as Senior Scientist and soon became Group Leader in Sterile Formulations Group. In addition to his industrial experience, his 20 years of teaching includes Adjunct Professorship at Fairleigh Dickinson University, Rutgers State University, Long Island University and University of Puerto Rico. He has conducted several courses for various trade organizations. His education includes M.S. and Ph.D. degrees from University of Wisconsin and a B.S. degree in Pharmacy from University of Jadavpur. He also holds a M.B.A. degree from Fairleigh Dickinson University. He is an Editorial Advisory Board Member of several journals and magazines and was an Advisory Panel Member of the United States Pharmacopoeia; Advisory Board Member of Alliance for Minority Participation–Universities of Puerto Rico and is a Board Member of Middlesex County College Foundation. He is a licensed pharmacist with many years of experience in hospital pharmacy. His industrial recognition includes over 150 presentations, 50 technical articles and 2 chapters in college books. He has moderated over 22 meetings/sessions. He has 17 patents issued and few more pending. For his industrial recognition, he has received APRS “Fellow” Award in 1988, Pharmaceutical Technology Publisher’s Award in 1996, AAiPS “Fellow” Award in 1999, Sarnoff Research Center Team Award in 1999, AAiPS “Outstanding Scientist” Award in 2001 and AAPS “Fellow” Award in 2006.
Priya Jambhekar has over twenty years of experience in the areas of product development, product safety, quality assurance, quality compliance and US and international regulatory affairs. She has extensive experience in establishing regulatory strategy and operational excellence for optimal success during all aspects of pre- and post- approval phases of drugs, devices and biologics development and marketing of products covering various therapeutic areas, including metabolism and endocrinology, analgesic, anti-inflammatory, cardio-renal, pulmonary, oncology, neuro-pharmaceutics, gastrointestinal, dermatology, ophthalmology, urology, pain, anesthesia and addiction products. Priya has significant experience in the generic industry and have successfully defended ANDA applications with Paragraph IV certifications. Strategies instituted by Priya have led to company getting a 6-month generic market exclusivity for block buster drugs and have maintained 2 player market for extended period of time. An Out-of-the-Box thinker and leader with an unique ability to work solo or manage a large international organization, with hands-on or –off basis. Priya also has extensive experience in handling of controlled substances, DEA and PDMA registrations, post market safety and medical communication and Health Care Compliance. Proven experience in handling FDA pre-approval inspections and product plant compliance. She has managed over 250 NDA / IND / ANDA / PMA / 510(k) projects in various stages of development for registration around the globe (US, EU, Japan, Canada, Asia, Australia, South and Latin America). Priya was a Global VP of Regulatory & Quality at Paramount BioSciences, Ethicon, a J&J company and Alkermes. Some of the other positions include, Baxter ACC as regulatory head and Bristol-Myers Squibb. Priya was a part of the management team at Cardiovations & GyneCare, J&J companies and Alkermes. Currently, Priya is a part of the management team of several companies advising companies on regulatory and quality matters, including CorMedix, Inc., Alacrity Biosciences, Edge Therapeutics and ChronoDose Therapeutics and is consulting with several small and large companies. Priya hold an M.Sc in Organic & Biochemistry and M.S. in Pharmacy. She is also certified by Regulatory Affairs Professional Society and NJ Pharmaceutical Quality Control and Assurance Society.
ICH Q3D guidance addresses presence of elemental metal impurities in the finished product but does not provide clear guidance on how to control these impurities, especially for those products that do not have established maximum daily exposure limits. Live
March 25, 2014
10:00 AM PDT | 01:00 PM EDT,
ICH Q3D guidance addresses presence of elemental metal impurities in the finished product but does not provide clear guidance on how to control these impurities, especially for those products that do not have established maximum daily exposure limits. This webinar will cover in great detail a complete review of the guidance document and USP general chapter on metal elements; classification of elemental metals, [class 1 being most toxic elements and class 4 where PDE information is available]; challenges to compliance with the guidance document, and steps to mitigate risks. At the end of the webinar, you will have a clear and thorough understanding of the ICHQ3 guidance and its impact. Recorded