Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractables and leachables have been developed and applied by pharmaceuticals and biologics manufacturers. These approaches may differ depending on the nature of the final drug product, the formulation, the route of administration and the length of use. Available regulatory guidelines provide compound-specific indications but do not provide a general and comprehensive approach to safety evaluations of leachables and/or extractables. This webinar provides a general overview of this topic and the possible approaches to safety evaluations of extractables and leachables.

Course Objectives:

An effective extractables and leachables evaluation is essential for the overall success of any pharmaceutical drug development program for both small molecules and biologicals agents. In this webinar expert speaker Stefano Persiani will focus on the basics of an effective extractables and leachables program. A case study will be presented to further provide focus on the concepts discussed.

Course Outline:

• Understanding of the different types of extractables and leachables
• Recognize the importance of extractables and leachables evaluations
• Learn the necessary steps of extractables and leachables evaluations
• Learn how to deal with extractables and leachables associated with potential safety concerns
• Learn the concept of Permitted Daily Allowance
• Recognize the difference between extractables and leachables assessment when the active ingredient is a small molecule or a biological product
• Influence and motivate cross-functional colleagues to embrace their critical roles in successful extractables and leachables evaluation programs

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Project managers
• Licensing managers
• Quality control and assurance managers
• Corporate quality managers
• Toxicology specialists
• Drug supply and manufacturing operations
• Senior management
• Quality assurance and plant management personnel
• Pharmaceutical development managers
• Formulation specialists
• Regulatory specialists
• Clinical Research Associates
• Clinical study monitors
• Consultants
• Quality system auditors