Course offering number:0811-205
Course ID:
1808
IQ, OQ, PQ
November 11-12, 2008
Burlingame, CA
Please be advised this course has been rescheduled to January 21-22, 2009. For more information please contact Customer Service at 732-613-4500 or info@cfpa.com
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, 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 current on-going
activities to provide International Consensus Standards being
considered by the Industry and Regulatory authorities to
define future Qualification requirements. Protocol
examples/workshops will be utilized to enhance the learning,
however this course will not provide a library of completed
protocols.