Ronald D Snee. PhD, Snee Associates, LLC, Newark, DE 19711The scientific method is fundamental to the operation and success of the pharmaceutical industry including the discovery of new products, development of the products using clinical trials and the manufacture of the products. The scientific method has three key components:Recognition and formulation of a problem Collection […]
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]
Presented by: Raul Soto, Senior Principal Quality Engineer, Johnson & Johnson
Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
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