Why Should You Attend:
A drug product must maintain its identity, strength, quality and purity till 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. On completing this session, attendees will learn key factors that would affect the shipping and distribution of drug products. Participants will understand product stability profile, typical environmental conditions for storage, and anticipating environmental extremes for distribution. This information will be necessary to design shipping conditions in order to maintain quality of the drug product till expiry.
Areas Covered in the Webinar:
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 of raw material and ingredients
Analysts and lab managers
QA managers and personnel
Regulatory affairs personnel
Kim Huynh-Ba
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s consent decree on harmonization and optimization of analytical best practices. Prior to this position, she was the director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analyses and analytical chemistry graduate courses.
ComplianceOnline
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.
Note: Use coupon code 232082 and get 10% off on registration.
A drug product must maintain its identity, strength, quality and purity till 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. On completing this session, attendees will learn key factors that would affect the shipping and distribution of drug products. Participants will understand product stability profile, typical environmental conditions for storage, and anticipating environmental extremes for distribution. This information will be necessary to design shipping conditions in order to maintain quality of the drug product till expiry.
Areas Covered in the Webinar:
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 of raw material and ingredients
Analysts and lab managers
QA managers and personnel
Regulatory affairs personnel
Kim Huynh-Ba
Kim Huynh-Ba has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. She is the executive director of Pharmalytik, where she provides consulting and training services to pharmaceutical companies including companies operating under FDA’s consent decree on harmonization and optimization of analytical best practices. Prior to this position, she was the director of Pharmacopeial Education Department of U.S. Pharmacopeia (USP), where she was responsible for their education programs worldwide. Ms. Huynh-Ba has held several technical and quality positions at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. She is also a short course instructor on cGMP compliance and quality topics for several global organizations such as American Chemical Society (ACS), American Association of Pharmaceutical Scientists (AAPS), Pittsburgh Conference, and many other international training groups. She is an adjunct professor at Temple University-School of Pharmacy, Widener University and Illinois Institute of Technology teaching pharmaceutical analyses and analytical chemistry graduate courses.
ComplianceOnline
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.
Note: Use coupon code 232082 and get 10% off on registration.
