Description
<strong>Course Schedule - January 21-22, 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 and facilities must
be accepted as fit for use, 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. A Risk Based approach
to impact and critical component assessment is also provided
along with an overview of the new ASTM International
Consensus Standard beginning to be applied by the Industry
and Regulatory authorities to define future Qualification
(Verification) requirements.<br><br>
Protocol examples/workshops will be utilized to enhance the
learning, however this course will not provide a library of
completed protocols.
