Study to Support Shipping and Distributing Pharmaceutical Products
Wednesday, February 5, 2014 from 10:00 AM to 11:30 AM (PST)
This training on pharmaceutical stability studies will highlight the key factors that would affect the shipping and distribution of drug products. It will explain the stability studies that need to be done to support shipping and distribution of drugs
Why Should You Attend:
Drug Product must maintain its identity, strength, quality and purity throughout its expiration. Physical, chemical and biological data are influenced by various environmental factors such as temperature, humidity and light. In current manufacturing environment, products can be shipped and distributed across different climatic zones. Seasonal changes as well as types of transportation can greatly affect the supply chain of the products.
This webinar will outline stability studies to support shipping and distribution of drug products. Upon completion of this session, attendees will learn key factors that would affect the shipping and distribution of drug products. you will understand the product stability profile, typical environmental conditions for storage and anticipating environmental extremes for distribution. These data will be necessary to design shipping condition in order to maintain quality of the drug product through expiry.
Areas Covered in the Seminar:
- Goal of stability studies.
- Warning letters and observations on shipping and distribution practices.
- Short term excursion study.
- Thermal cycling study.
- Analytical testing for these studies.
Who Will Benefit:
- Pharmaceutical scientists
- Manufacturers or raw material and ingredients
- Analysts and lab managers
- QA managers and personnel
- Regulatory affairs
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.