Course offering number:0901-401
Course ID:
1808
IQ, OQ, PQ
January 21-22, 2009
Boca Raton, FL
Who Should Attend
This introductory course is designed for individuals who need
a basic, but thorough understanding of the Validation Process
for equipment and processes used in the manufacturing of
pharmaceutical sterile and oral solid finished dosage forms
and bulk active ingredients through the use of IQ/OQ/PQ
Protocols. The course will benefit individuals in:
• Engineering
• Technical Services/Validation
• Production
• Quality Control/Assurance
• R&D
• Regulatory Affairs
• University and allied health care professionals
Description
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.
Protocol examples/workshops will be utilized to enhance the
learning, however this course will not provide a library of
completed protocols.