Description

Summary : A RAPS pre-approved webinar on the topic, “Auditing an Active Pharmaceutical Ingredient (API) Contract Manufacturing Organization (CMO)” is being held by GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider on July 24. This webinar earns 1.00 RAC credits towards a participant's RAC recertification upon full completion. The speaker of this 60-minute webinar will be Max Lazar, a well-known consultant on API GMP issues.

Description: API manufacturing and drug products have more or less similar regulatory expectations, but these are different as far as specific requirements and applications are concerned.
Given this fact, it is very important to understand the FDA's expectations and requirements on API processes. The webinar will focus on the Q7 and FDA GMP requirements, what are the key contractual requirements, and what should be negotiated and documented within quality agreements with a CMO firm.

The webinar will benefit
o Supervisors and Managers in Manufacturing
o Supervisors and Managers in Quality
o Engineering
o Maintenance Supervisors and Managers
o Warehousing and Materials Management Supervisors and Managers

By whom : Max Lazar is a highly decorated and accomplished expert on API and related areas. After having served Hoffman-La Roche for over 35 years, he retired and established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7A Guidance and the Excipient GMP (IPEC) Guidance.