Managing contractors is key to successful operations. As companies continue to outsource processes, the quality agreement becomes critical to supply chain operations. Quality agreements are required by the EU GMPs and are recommended per the International Conference on Harmonization's (ICH) Q10, known as Pharmaceutical Quality System.

This audio conference discusses what a quality agreement is and how to use it as a tool in managing your contractors. It also identifies the key elements of what to include in the quality agreement so that if something goes wrong, responsibilities have been clearly delineated and corrective action can proceed smoothly.

This audio conference covers:

• The challenges of managing contractors
• What is a quality agreement
• How to succeed in managing contractors
• What to include in a quality agreement
• How to negotiate and monitor the quality agreement

About the speaker:

Marion Weinreb, President, Marion Weinreb & Associates, Inc., provides strategic consulting expertise in quality systems and cGMP compliance. She focuses on GMP and/or QSR auditing in both non-sterile and sterile drug and device systems, pre-approval inspection preparation, mock audits, quality systems development and continuous improvement, cGMP training, GMP document development and problem resolution for compliance issues.

Marion has had over 33 years of quality assurance experience in the pharmaceutical and medical device industries, with increasing managerial responsibilities. She has worked for small and large companies, and has a successful track record for dealing with complex compliance issues in development and commercial settings.

Who should attend?

• Quality Assurance Managers/Directors
• Operations Managers/Directors
• Clinical Quality Assurance Managers
• Product Development Managers
• Clinical Operations Managers