2nd CMO Quality Oversight & Risk Management

Feedback from our inaugural CMO Quality Oversight & Risk Management Conference in Boston, MA (April, 2011) was tremendous, of which we had 90+ participants from 45+ multiple-sized pharmaceutical and biotech companies sharing critical CMO oversight and management strategies.

Back by popular demand, ExL Pharma’s 2nd CMO Quality Oversight and Risk Management Conference will provide a platform for quality, manufacturing and auditing professionals to hear case study examples, share best practices and discuss strategies for improving quality management systems, CMO oversight strategies, designing quality agreements and conducting and preparing audits.

By attending this conference, you will hear industry-specific case studies and examples including:

• Performing risk assessments and due diligence within the selection process of your CMO
• Assessing risk management of the quality system of your CMO
• Preparation for FDA inspections, and compliance strategies regarding CMO oversight
• Improving product quality throughout your outsourcing relationship
• Applying risk management to vendor assurance and supplier management in development
• Novel approaches to external partner and product knowledge across the lifecycle
• Effective supplier oversight through multi-partner quality agreements for a complex supply chain
• Auditing regulatory compliance within a contract manufacturing business scenario
• Comparing relationship management for clinical and commercial manufacturers
• Working with an overseas CMO to gain FDA inspection and approved status
• Examining and assessing quality oversight challenges faced by virtual companies

This will be an intensive training course for multiple-sized pharmaceutical and biotech companies, as well as CMOs to learn, benchmark and understand key criteria needed in order to effectively manage the outsourced manufacturing partnership from beginning to end.

What will you learn?

• Preparation for FDA inspections of manufacturing facilities and communicating effectively with your partner to accurately record and display data efficiently
• Aligning your corporate philosophy and your CMO outsourcing Strategy to achieve business objectives
• Applying a risk management system to vendor assurance and supplier management in development
• Implementation of quality systems within your outsourced manufacturing supply chain
• Creating multi-partner quality agreements for a complex manufacturing supply chain

Additionally, do not miss the pre-conference workshop "Protecting Your Outsourced Manufacturing Supply Chain Through a Risk-Based Approach to Quality Aggreements"

Testimonials

“Very good content, revevant for my needs and most others” - SENIOR MANAGER, GLOBAL COMPLIANCE, BAXTER

“Very good overview for full lifecycle of CMO oversight issues and challenges!” - DIRECTOR, QUALITY OPERATIONS, ABBOTT LABORATORIES

“This conference provided the best advice and oversight strategies for me to take back to my comany and implement” - SENIOR MANAGER, QUALITY AUDITS, MILLENNIUM PHARMACEUTICALS

“Excellent! This is what I wanted to hear. Good practices and practical experience.” - REGIONAL EXTERNAL SUPPLY QUALITY LEAD, GLAXOSMITHKLINE