The Center for Professional Advancement, Amsterdam
29-30 November 2007
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.
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