Stability Operations for Drugs, Biologics and Medical Devices; Steps to a Successful Stability Function

From the event website: This 12-hour accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample [...]

KENX Laboratory University / PSDG 2023 Meeting

San Diego, CA San Diego, CA

PSDG Meeting /  Laboratory University contains 3 amazing tracks at one location! Each track contains a packed agenda of current regulations, industry trends and key areas of interest. Customize your experience by choosing from over 50 sessions. Topic areas include: Analytical Procedures & Methods Validation, Stability Testing & Program Management, Lab Management and QC Excellence. [...]

Introductory CMC Analytical Studies and Lab Quality Practices

Course Overview (from website): This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical, and quality elements necessary to assure successful planning and documentation of the required CMC analytical and stability studies for biological products. Key data deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC [...]