Auditing to Monitor the Excipient Manufacturer – Partnering for Success

Wednesday, June 13, 2018 - 11:00am

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.

Presentation Objectives

  • 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)

Presenter(s)

Ralph Lindblad

Product Quality Manager
Catalent Pharma Solutions

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.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org