IQ, OQ, PQ
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Who Should Attend
This introductory/intermediate course is designed for
individuals who need a basic, but thorough understanding of
the Qualification Process for equipment and systems in
support of Process Validation for the manufacture 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/
verification 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 critically assessment is also provided along with an
overview of ICH Q9 Quality Risk Management and ASTM E
2500 International Consensus Standard approaches being
applied by the Industry and Regulatory authorities to define
Qualification (Verification) requirements.
Protocol examples/workshops will be utilized to enhance the
learning, however this course will not provide a library of
completed protocols.