Pharmaceutical Dosage Forms - Parenteral Medications Volume 3: Regulations, Validation and the Future

Volume 3: CGMP Regulations of Parenteral Drugs L Terry E. Munson Risk Assessment and Mitigation in Aseptic Processing L James Agalloco and James Akers Validation of Drug Product Manufacturing Processes: NCEs and NBEs L Karoline Bechtold-Peters Visual Inspection L Maria Toler and Sandeep Nema Advances in Parenteral Injection Devices and Aids L Donna L. French and James J. Collins, Jr. SiRNA Targeting Using Injectable Nano-based Delivery Systems L Lan Feng and Russell J. Mumper Excipients for Parenteral Dosage Forms: Regulatory Considerations and Controls L Sandeep Nema Techniques to Evaluate Damage and Pain on Injection L Gayle A. Brazeau, Jessica Klapa and Pramod Gupta Parenteral Product Specifications and Stability L Michael Bergren Extractables and Leachables L Edward Smith and Dianne M. Paskiet Process Analytical Technology and Rapid Microbial Methods L Geert Verdonk and Tony Cundell Quality Assurance Michael Gorman L Application of Quality by Design in CMC Development L Roger Nosal, Tom Garcia, Vince McCurdy, Amit Banerjee, Carol F. Kirchhoff, Satish K. Singh Future of Parenteral Manufacturing L James Agalloco, James Akers, and Russell Madsen

Biography

Sandeep Nema Ph.D. is Executive Director, Pharmaceutical R&D, BioTherapeutics Pharmaceutical Sciences at Pfizer in St. Louis. Since graduating in 1992 with his doctorate, Dr. Nema has been involved with the development of small molecule and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia), and has led the formulation of four launched products. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA), where he has chaired several meetings and focus groups. Dr. Nema holds an adjunct faculty appointment at the University of Tennessee.

John D. Ludwig Ph.D. is Vice President, Business Strategy, Operations, and Clinical Supply Planning, BioTherapeutics Pharmaceutical Sciences at Pfizer, and Site Director for the company's St. Louis Laboratories. Dr. Ludwig received a B.S. degree in Pharmacy and Ph.D. degree in Pharmaceutics from the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle, Inc., Pharmacia, Inc., and Pfizer. He is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute, where he has contributed to developing professional training courses and has regularly served as an instructor.