Pharmaceutical API, Drug Substances, Excipients and Raw Materials Testing

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
90 minutes
Product Description

Get a Lowdown on the Rules and Regulations For Receipt and Testing of APIs, Excipients and Raw Materials in the Pharmaceutical Industry.

Over the past several years, the FDA has made a number of observations that some firms have not performed adequate testing of incoming APIs, components and raw materials. These regulatory requirements are defined in GMPs.

Due to recognized problems in the incoming material supply chains, the FDA is placing more emphasis on material quality. But, on the basis of the stated observations it appears that some organizations have misinterpreted or chosen to ignore the regulatory expectations.

One of the priority items in an FDA inspection is a review of how the organization handles out-of-specification (OOS) test results. This has resulted is a great number of observations reported in FDA 483s and Warning Letters. The Warning Letters demonstrate that organizations do an inadequate job in the investigation of OOS results and the corrective and preventive actions that should follow.

This 90-minute session by expert speaker Jerry Lanese will discuss the regulations within the GMPs that apply to the receipt and testing of APIs, excipients and other components of a pharmaceutical product. It will include reference to specific FDA observations and an analysis of what happened and actions to avoid similar observations and practical considerations in achieving compliance with FDA. Going further, it will also help the personnel in the quality control laboratory understand what the FDA expectations for incoming materials testing are, and the role of Quality Control in achieving compliance in the area of incoming material testing and release.

Session Highlights:

  • Regulatory requirements for the testing and release of APIs, excipients, raw materials and components of pharmaceutical products.
  • Regulatory expectations for the testing and release of incoming APIs, raw materials and components in the pharmaceutical industry.
  • FDA observations that relate to the testing and release of APIs, raw materials and components.

Training Content:

  • Overview
  • The Challenge
  • Steps for Internally Produced Materials
  • The regulations, observations and discussion
  • Retest procedure
  • The Steps – Incoming Materials
  • Interactions with the supplier

Who Should Attend

  • Development personnel who identify and negotiate agreements with API, raw material and component suppliers.
  • Quality and purchasing personnel who identify API, raw material and component suppliers and develop and negotiate quality agreements with material and component suppliers.
  • Quality personnel responsible for the preparation of specifications and test methods for incoming materials.
  • Quality Control personnel who are responsible for the testing and release of API, components and raw materials
  • Quality Assurance personnel responsible for the release of API, raw material and components

Order Below or Call 1-866-458-2965 Today

You can also order through:

1-866-458-2965

1-919-287-2643

About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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