Studies to support Temperature Excursions and Shipping of Pharmaceutical Products
Duration : 90 Minutes
Kim Huynh-Ba,
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She currently is the Executive Director of Pharmalytik. Since 2003, she has provided consulting and training services to pharmaceutical companies, including companies ope Read more
Supply chains now span the globe and are increasing in complexity. Shipping of pharmaceutical products could involve long and complex routes that may require temperature controlled environments. Manufacturers must assure the products maintain its safety, efficacy and overall quality on release as well as throughout the distribution as part of Quality Management System (QMS). The need of regulations, guidelines, industry standards and established service providers to support this area has increased significantly. Establishing an effective strategy require a thought-through integration of scientific data and product understanding to evaluate temperature excursions, packaging breakdowns, incorrect shipping or custom delays could cause detrimental effects and derail critical clinical studies or commercial launch.
This webinar will discuss the complexity of the storage and distribution of pharmaceutical products and the effect of environmental factors during transportation and distribution. It will also discuss temperature-cycling studies could be set up to support temperature excursions during shipping of pharmaceutical products depending on their label storage conditions.
Course Objective:
Upon completion of this session, attendees will understand key factors that affect stability profile and making plan for extreme environments for distribution pharmaceutical products. These data will be necessary to design shipping condition in order to maintain quality of the drug product through product expiry.
Course Outline:
• Understand the effect of shipping and transportation
• Ensure appropriate conditions (temperature) are maintained throughout.
• Understand the complexity of supply chain and distribution
• Maintain the product safety and integrity
• Purpose of stability studies and environmental factors
• Establish studies to support temperature excursions
• Risks encountered during transporting and distributing pharmaceutical products.
• Temperature cycling studies to support shipping and storage excursions
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Analytical chemists
• QC managers
• QA managers
• Compliance managers
• Lab managers
• Sale managers
• Distributors and manufacturers of raw materials and ingredients
• Individuals who are responsible for storage, shipping and distributing products through the supply chain
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
