Course 1 Faculty
Lori Richter, Senior Consultant, Valsource, LLC
Lori Richter is a Senior Consultant at ValSource. She holds a Microbiology degree and over 18 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Her most recent role included developing an Integrated Risk Management program focused on strategic risk and business continuity management. Prior to that she held a global team role, developing and deploying a Quality Risk Management (QRM) program across the Roche Pharmaceutical Division, including developing tools, templates, and training materials, and integrating QRM into Quality Systems. She is currently a team member of the Parenteral Drug Association (PDA) Task Force, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”, authoring TR 54-5.
Amanda B. McFarland, Senior Consultant, Valsource, LLC
Amanda Bishop McFarland, M.S. is a Quality Risk Management and Microbiology Consultant with Valsource, LLC with over 15 years industry experience. She specializes in the creation and implementation of Risk Management programs and in developing risk-based strategies for use in Microbiology. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology both from the University of Florida. Amanda is an active member of the Parenteral Drug Association (PDA); a faculty member of the PDA’s Quality Risk Management training series and the Quality Risk Management Interest Group co-lead.
Course 2 Faculty
Ghada Haddad, Director, Global Quality Risk Management CoE, Quality Assurance and External Affairs, Merck and Company
Ghada Haddad is currently a Director at Merck & Company, leading the Global Quality Risk Management (QRM) Center of Excellence. She holds a chemistry degree and an MBA with over 18 years of experience, working in the Biotech and Pharmaceutical industries starting with Hewlett- Packard, Agilent Technologies, Genentech, Roche and now Merck in the areas of Qualification and Validation, QRM, Quality Systems and Regulatory, including research, process development, auditing, regulatory agency inspection, change control. Ghada is a PDA Board of Director member as well as a member of the Science Advisory Board. She was the task force leader of the Paradigm Change in Manufacturing (PCMO) initiative for TR54-2, QRM in Packaging and Labeling, TR54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems, co-chair of the Aging Facility Points to Consider, a member of TR54-3, QRM in the Manufacturing of Pharmaceutical Drug Products, and a contributor to TR54, Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations. Ghada is also a Faculty member for PDA’s Training and Research Institute and a frequent speaker at PDA conferences as well as a member of the Annual PDA planning committee for the past 3 years.
Scott Rudge, COO and Chairman, RMC Pharmaceutical Solutions, Inc
Since co-founding RMC Pharmaceutical Solutions in May 2004, Scott has been involved in a wide variety of projects for small and large biotech/pharmaceutical companies. He has overseen and/or performed assay, equipment, sterilization, cleaning and process validation, formulation development, due diligence for a multimillion dollar investment, construction of a new GMP facility for tissue processing, and tech transfer for a major late stage biotechnology product. In his last position, Scott served as the Vice President of Operations at FeRx Incorporated, overseeing manufacturing, process and product development, analytical development, formulation, facility design, construction and operation, and intellectual property.