Pharmaceutical Production and QA/QC Records and Reports
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Who Should Attend
This course is designed for those interested in or responsible for
preparing, issuing, managing or using records or reports
associated with the production or QA/QC aspects of drug
products, APIs (Active Pharmaceutical Ingredients) or excipients,
either for commercial use or for development use including clinical
supplies. It will also be of interest to those responsible for
compliance with FDA requirements. Typically, such individuals
include personnel from manufacturing, packaging, distribution,
QA, QC, regulatory affairs, process development and validation.
Description
The "Records and Reports" section of the FDA’s cGMPs for drugs includes requirements for several different types of records
and reports. Guidances for APIs (Active Pharmaceutical
Ingredients) and Excipients have similar requirements. This course
addresses how these requirements can be met without
compromising effectiveness and efficiency. In particular it
addresses, in detail, what the records and reports are, what they
should contain and how they can be prepared and used. In
addition to lectures, the course includes “hands on” workshops
in which participants deal with case studies. The faculty includes a
former FDA Officer who will provide the FDA’s viewpoint on each
topic as it is presented.