Validation and quality assurance play a crucial part in the manufacturing process. This area is often overlooked, and could impose delay in product launch – and worst, put patients’ safety at risk.
What is the best practice of validation and quality risk management during AP and sterile manufacturing? Instead of a tick box exercise, learn how to customize this to suit your business needs, and translate your validation framework into robust testing and well executed risk program.
Attendees will be able to discuss and be inspired at this session with scenario based case studies, and understand:
• What a risk management approach is in regards to AP and sterile product manufacturing
• How to apply this approach to minimize potential failures and delays in the project or to ensure the manufacture of quality products through case studies and examples
• How and where to focus your efforts to maximize the returns on your validation dollar
Workshop Leader: Tony Van Hoose, CEO, Global Aseptic Process Solutions, LLC
Understanding your projects’ specific technical needs, and working with your partners strategically to ensure your project is delivered on-time and on-budget, is not a straightforward exercise in
today’s complex regulatory and technical environment. Too often, pharmaceutical companies struggle to meet aggressive timelines for new products’ introduction and/or major capacity expansion. Also, working with many different vendors, internal colleagues and across multiple time zones, leads to delays and cost overruns.
Join with colleagues from other firms and industry experts to learn and discuss:
• How to best translate science into business
• Define practical, realistic requirements and expectations for advanced aseptic processing to senior management, your equipment providers and CDMOs
• What the risks to time/cost are, and understand proven techniques to mitigate them
• Setting expectations and getting it right first time to ensure transformation is on-time and on-budget
Workshop Leader: Paul Gold, Principal, Pamigo Aseptic