PDA/FDA Container Closure Components and Systems Workshop 2013

Container Closure Systems must be suitable for continuously developing therapies and manufacturing technologies. The main pillars for suitability: protection, compatibility, functionality and safety take on new meaning as a maze of quality considerations emerge with the onset of risk based management couple with demands of innovative medicines. This 1 1/2 day workshop will tie together a broad scope of attributes for container closure systems and potential impact to quality of therapies from the point of component selection, to the manufacture of medicine and delivery to patient.

Quality attributes span a wide spectrum of considerations and should be predetermined for intended use, established based on proven chemical, physical and functional characteristics. This program will explore the requirements, trends and applications of quality expectations for container closure systems in relation to the patient expectations.

Learning Objectives
At the completion of this workshop, you will be able to:
• Describe Materials used in the Manufacture of Parenteral Packaging Components
• Explain Engineering Packaging Components and their Delivery System to meet Requirements of Today and Future Therapies
• Validate the Manufacture of Parenteral Products to Secure Integrity of the Container Closure System
• Discuss Insights Associated with Qualifying Components of Combination Products
• Explain the New Age of Protection and Safety of Drug Products During Storage and Distribution