When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations; recently, quality issues, i.e. for biopharmaceuticals, have become an additional concern.
This education series (pre-recorded webinars combined with live discussions at the end of each day) will look at Extractables and Leachables (E/L) from many different angles:
- Regulatory Requirements and Guidelines
- Materials and Polymer Science
- Mechanisms of Leaching and Material-Drug Product Interaction
- Analytical E/L Methodologies
- E/L Study Design for Different Packaging Systems
- Large Volume Parenterals
- Lyophilization Applications
Several interesting case studies on the above topics will also be presented.
At the end of each day, trainers are available to answer questions in a Live Q&A session.