As both the industry and regulators move towards a greater understanding of the truly critical components of a comprehensive quality system, industry practitioners are challenged with determining the most effective and efficient means to ensure quality from as early on as the research phase all the way through commercial manufacturing.

This unique conference focuses on industry-specific tools and techniques available for Quality Assurance and Quality Control personnel to analyze current procedures and documentation protocols to enhance their regulatory compliance.  Through a combination of interactive sessions and workshops this event analyses the historical elements of the quality systems and investigates the opportunities to improve efficiencies and ultimately meet the goal of ICH Q10 initiative for overall process improvement for quality systems.

Partner, Paule Drouault-Gardrat to speak regarding:

Create a Standard Procedure to Ensure a Successful EU cGPM Pre-Approval Inspection

Examine the rules governing an EU inspection and understand how EMEA inspections differ from those of the FDA. This session provides insights regarding what the milestones are leading up to an inspection and what to expect on inspection day. Understand how to identify who you should have in place for the inspection, receive tips on how to manage the inspection and explain what to expect post inspection.

• Understand what the milestones are for inspections and base line expectations
• Procedures establish and ensure a successful meeting
• Evaluate the personalities in your organization that best fit an inspectional team

To learn more click here.