IQ, OQ, PQ
November 04 - 05, 2009
Burlingame, CA
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Who Should Attend
This introductory/intermediate 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 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.
Other Courses of Interest
Commissioning, Qualification and Validation
Biopharmaceutical Process Systems
Pharmaceutical Process Development
Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9
Process Validation for the Pharmaceutical and Medical Device Industries
Root Cause Investigation for CAPA
Apr 12 2010, New Brunswick, NJ
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Apr 26 2010, Amsterdam, The Netherlands
Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes)
Jun 07 2010, New Brunswick, NJ
Sterile Products: Formulation, Manufacture and Quality Assurance
Apr 26 2010, New Brunswick, NJ
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