This webinar will delve into various aspects of a sterility assurance program for pharmaceutical products, emphasizing its critical role from the early stages of product development through the entire product lifecycle. The discussion will contextualize sterility assurance within the product lifecycle, providing practical examples of its application.
Key topics addressed in this webinar include:
- Product and Packaging: Learn how sterility assurance begins with the design and selection of appropriate product packaging to ensure the integrity and sterility of pharmaceutical products.
- Manufacturing Process Design: Understand the importance of designing manufacturing processes that uphold sterility, including considerations for facility layout, equipment selection, and operational procedures.
- Evaluation and Selection of Materials: Gain insights into evaluating and selecting materials that support sterility, including raw materials, components, and packaging materials.
- Microbiological Process Controls and Testing: Explore the microbiological controls and testing methods necessary to monitor and maintain sterility throughout the manufacturing process, including routine monitoring and environmental controls.
- Sterility Assurance Validation and Maintenance: Discover the validation processes required to ensure sterility, including the development and implementation of validation protocols. Learn about ongoing maintenance practices to sustain sterility assurance over the product’s lifecycle.
- Change Control: Understand the importance of change control in sterility assurance, including how to manage changes in materials, processes, or packaging that may impact sterility.
By participating in this webinar, attendees will acquire a comprehensive understanding of sterility assurance and its integration into pharmaceutical product development and lifecycle management. This knowledge is essential for ensuring the safety and efficacy of pharmaceutical products and maintaining regulatory compliance.
This webinar is ideal for professionals involved in pharmaceutical development, manufacturing, quality assurance, and regulatory affairs. Join us to enhance your expertise in sterility assurance and ensure the highest standards for your pharmaceutical products.