• Understanding the Regulatory Expectations for a Successful Single Use Biomanufacturing System

The Regulatory View on Disposable Bio manufacturing, Submission Criteria and Approval Processes   

• Understanding the approval process for biologics and the manufacturing considerations
• The expectations for submission criteria for disposable manufacturing processes
• Working examples of good and bad practice: overcoming the challenges

Preparing for Regulatory Submission: Our Experiences

• The approach to regulatory submissions and ensuring a water tight application
• Effective solutions to gaining first time regulatory approval
• Achieving thorough validation
• Analyzing  regulatory experiences, the pitfalls and how they were overcome

• Achieving Validation and Complete Process Mapping for Disposable Systems

CASE STUDY: Developing an Effective Validation Method

• Introducing validation program
• Refining the development process and understanding the challenges and solutions
• Maximizing time savings and minimizing costs by implementing a thorough validation program

• Understanding how to Apply Quality Assurance to Single Use Equipment Suppliers

There will be 2 main themes of this cross-sector panel, where industry experts and suppliers will come together and discuss how to assess the liability of suppliers and end users through implementing inspection and audit programs and ensuring effective change management.  There will also be a closer look at the various approaches to sampling and testing of single use sterile devices.

• Assessing the Time and Cost-Saving Potential of Disposable Manufacturing Systems and Matching the Best System to your Processing Requirements

CASE STUDY: Evaluating the When and How of Single Use Systems to Ensure Cost-Efficiency at All Stages

• Considerations when developing large scale disposable systems
• Assessing the length of the project, scale ups and capacity requirements
• Overcoming capacity limitations: is a hybrid system the only solution?
• Drastically reducing set up time and increasing agility through single use systems

Applying Risk Management Strategies when Implementing Single Use Systems

•  Drastically reducing set up time and increasing agility through single use systems
•  An overview of our approach to implementing a full SUS
• Employing effective supplier selection criteria and stakeholder management techniques/solutions
• The risk management process: development and execution
• Successfully enhancing the product lifecycle and achieving process validation
• Investigating the importance of comprehensive project management to drive the profitability of the manufacturing process.