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View Sub-Track: Regulatory
Wednesday, March 26, 2008
C-1: Implementing a Global Risk Assessment Process 9:00AM - 10:00AM (Wednesday, March 26, 2008)
This presentation will share experiences of participating in a global team to develop and implement a Computer System Validation Risk Assessment process, in a large R&D organization. An overview of the content of the Risk Assessment Guidance documentation and supporting tools, present the outcome of the process (with examples) and lessons learned.
C-2: Breaking Down Barriers for the FDA's Quality by Design 10:15AM - 11:15AM (Wednesday, March 26, 2008)
Recent research conducted by Conformia for the FDA through FDA-Conformia CRADA, revealed that one of the biggest challenges and opportunities stems from the way in which critical product/process science knowledge is captured, stored and retrieved. One of the biggest causes of the difficulties is the ability to access, track and leverage knowledge from R&D -- i.e. experimental data and conclusions that are often buried in multiple silos across the product/process lifecycle. It's often a mystery as to the who, what, where, why and how of development This is particularly important in light of FDA's forward vision for Pharmaceutical development based on ICH Q8 and Q9 an encapsulated in concepts such as Quality by Design. These forward driving approaches necessitate companies being able to submit very good high quality information supporting the science and understanding across the product / process lifecycle.
C-3: Cleaning Validation in Non-Sterile Solid Dosage Production 2:00PM - 3:00PM (Wednesday, March 26, 2008)
This presentation describes practical approach for Cleaning Validation in Non-Sterile Solid Dosage Production, including development of governing documents, assignment of responsibilities, usage of the project management tools in performance and completion of the tasks and other cornerstones of this fundamental activity. What makes this presentation unique is presentation of the multiple case studies that include development and validation of cleaning methods. Most importantly, presentation describes usage of Process Cleaning Records, as an efficient, validatable procedure that assures consistent successful cleaning.
Igor Gorsky - Associate Director, Validation, Global Pharmaceutical Technology, Shire Pharmaceuticals, Inc.
C-4: Real Lessons from the Validation of Enterprise Solutions 3:15PM - 4:15PM (Wednesday, March 26, 2008)
The session would provide updated insights on how to balance the critical business objectives that drive any Enterprise System (ERP, CRM etc) project with the need to cost-effectively validate the system and ensure that business processes are regulatory compliant. Using real-life project examples and input from a end-user, the interactive workshop would be organized to seek input from conference delegates and provide practical and pragmatic answers to questions posed during the session.
David Stokes - Global Head of Life Sciences, Business & Decision
Thursday, March 27, 2008
C-5: Pharmaceutical Manufacturing - The Challenge of Global Regulatory Compliance 9:00AM - 10:00AM (Thursday, March 27, 2008)
In the competitive pharmaceutical/ biotechnology industry, companies seeking to market products in new countries must strive to secure marketing authorization from government agencies in a smooth and timely fashion. A critical step to ensuring prompt approval is the need to demonstrate compliance with local regulatory agency manufacturing requirements. Inter-agency variations in regulatory demands can present significant challenges in navigating the approval process and assuring ongoing compliance. Prior knowledge or experience is essential to ensure the smooth implementation of processes and procedures that satisfy the needs of multiple international agencies and minimize the potential for costly production delays. First hand experience gained from multiple international submissions and manufacturing site inspections has established the need to: remain constantly apprised of regulatory changes; be mindful that differing interpretations of simple international guidelines that can hinder the approval process and beware the perils of taking compliance for granted. This presentation will provide an overview, discussing the challenges of simultaneously navigating both the demands of multiple international regulatory agencies with the differing and ever changing requirements across the pharmaceutical manufacturing continuum.
Speaker:
Kelly Davis - Manager of Regulatory Affairs, Baxter Healthcare Corporation
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