The webinar was originally recorded on May 13, 2018. Effectively auditing an excipient supplier (from the pharmaceutical perspective) requires more than just checking off boxes on a questionnaire or from a check list! Supplier and excipient assessment and qualification is a multi-step process that includes the exchange of information between parties. The need for accurate, reliable and detailed information is critical, and relationship building is one important element for an effective supplier assessment.
- Outline the importance of relationship building
- Describe potential pitfalls of group auditing for makers and users
- Explain the role of 3rd party certifications
- Discuss best practices for effective monitoring of suppliers through the use of Risk Assessment. Get process details that help make incoming inspection scientifically valid (e.g. understanding excipient homogeneity)
Ralph currently holds the position of Product Quality Manager for Catalent Pharma Solutions, a global partnering company specializing in pharmaceutical, biotech and consumer health innovation and manufacturing. He is engaged in Quality Assurance and Manufacturing in the Pharmaceutical and Medical Device disciplines for 35 years with a strong concentration in Supplier Quality for the past 10 years.