Description
<strong>Course Schedule - 18-19 February 2009</strong><br/><br/>The installation/operational/performance qualification of
equipment, systems, facilities, and processes for
pharmaceutical sterile, oral solid dosage, finished and bulk
manufacturing operations are an essential part of the
validation process. Equipment must be installed, operated,
and maintained within design specifications, while processes
must be shown to be reliable, all of which to assure the
consistent quality and integrity of the product. This course
provides a basic and thorough understanding to preparing,
executing, reviewing, and approving protocols.<br><br>
A <b>Risk Based</b> approach to impact and critical component
assessment is also provided along with an overview of the
current on-going activities to provide International Consensus
Standards being considered by the Industry and Regulatory
authorities to define future Qualification requirements.<br><br>
Protocol examples/workshops will be utilized to enhance the
learning, however this course will not provide a library of
completed protocols.
