Regulatory agencies are 'upping the ante' with regards to implied and written compliance. As they currently exist, the ICH guidance documents may or may not be issued. Our global marketplace makes it critical to understand the linkages between FDA, ISO and ICH requirements to have a quality system that meets all requirements in the broad customer base – in particular, 21CFR211/820, ISO 13485, ISO 9001 and ICH Q8, Q9, Q10 and IPEC 2006 requirements, similarities and differences.

Preparation for a successful audit, product approval and a compliant Quality Management System is key to compliance and ultimately, product and site approval. In this audio conference, our speaker draws on extensive experience in hosting regulatory agency and customer audits, as she shares practical experience and established best practice approaches.

This audio conference covers:

• Common findings and successful remediations
• ISO/FDA/IPEC overlapping requirements
• Documentation, documentation, documentation
• How to train staff for successful audits
• What does compliance look like?

About the speaker:

Susan Soderholm, ASQ, CQA, CSSBB has extensive experience in pharmaceutical manufacturing, medical device, clinical operations and packaging for pharmaceutical companies and the health sector in general. She has audited throughout the US and Europe, and has successfully trained quality auditors in multiple locations throughout the United States.

Who should attend?

• Quality Managers
• Quality Engineers
• Manufacturing Engineers
• Manufacturing/Operations Managers
• Regulatory Associates
• Operations
• Training Associates
• Clinical Operations Associates
• Documentation/Doc Center staff