GDP (Good Distribution Practices)

Wednesday, October 19, 2016 - 11:00am to 1:00pm

Excipient resellers (distributors and other non-manufacturing suppliers) are key and often essential players not only in providing excipients to the various developers and manufacturers of drug products, but also in improving security of the overall supply chain for drug products. Many excipient AND drug product manufacturers are both confused and confounded by the complexity of the excipient distributor / reseller world. This webinar is designed to facilitate the who, what, where, how and why of excipient resale, including a discussion of the application of the NSF/IPEC/ANSI 363-2014 Excipient GMPs to distributors of various types.

Presentation Objectives

  • Name some excipient supply chain "events" and why product quality for excipients is important
  • Recognize and distinguish between the various types of excipient suppliers, and what standards they should demonstrate adherence to based upon their scope     
  • Recognize and name the various Good Manufacturing Practices documents currently available for excipients and their corresponding relationships to excipient Good Distribution Practices
  • Given the NSF/IPEC/ANSI 363-2014 Excipient GMP standard, discern which requirements apply to the various distributor types
  • Understand and list steps to help assess excipient distribution supply chain steps and integrity whether you are a supplier or user

Presenter(s)

Linda A. Herzog

Training Technical & Membership Operations
IPEC-Americas
Since her tenure as a sales and marketing director at a major excipient distributor, Linda Herzog has been active in advocating stricter regulation of excipients, including GMPs and GDPs. Prior to that, she spent over 20 years in the chemical and excipient manufacturing industries.

Linda joined IPEC-Americas in 2015 as a training, technical and membership operations specialist. She is a key part of the IPEC-Americas Learning Laboratory Staff and Team, helping to provide valuable excipient training and education for excipient makers, users, distributors, regulators, and other stakeholders.

Pamela Malcontento

National Director of Quality
Univar

In her over 20 year career overseeing Quality in manufacturing and distribution of food and pharmaceutical products, Pam has focused on implementing highly conservative product safety systems and coaching for those adopting and continually improving to key standards.

Since joining Univar in 2013, Pam Malcontento has been focused on creating strong quality systems and a quality culture to differentiate Univar as a key partner to their Pharmaceutical as well as all other industry customers.

Cancellation Policy

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

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

IPEC-Americas Webinars
3138 10th Street
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 are unable to attend the webinar, a recording of the webinar will be provided to all registered persons.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org