66 2014 - The Basic Requirements for Developing IQ and OQ Protocols

Instructor: Kenneth Christie
Description:
Current regulatory requirements state the need to prove and document that equipment, systems and utilities are verified to perform their desired functions. This verification and documentation comes in the form of qualification protocols that verify proper installation, adequate support utilities, operation over its entire range, and acceptable performance according to established procedures and operational setpoints.
This webinar will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. Attendees will be given the chance to ask questions regarding their own protocols and actual case studies will be used to highlight various points.
This webinar will highlight the importance of establishing specifications, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
Why Should you Attend:
Any equipment, system or utility used for GMP impacted products or services must demonstrate they are suitable for their intended use and operate according to their design and functional specifications. To prove these requirements, the protocols developed for both installation and operational verification (and others) are expected to be in place, be based on defined user and functional specifications and approved prior to use. This webinar, designed for those just starting to be responsible for qualification activities, will help establish an outline of the basic components for these two protocols. Benefits of a good summary report are also briefly reviewed. In addition, common deficiencies cited by regulators will also be reviewed in order to help attendees avoid similar issues when their protocols are audited.
Objectives of the Presentation:
Review common protocol types and the typical information included in each
Discuss common deficiencies cited with each type
Review how best to summarize results and the handling of deviations encountered
Discuss questions that attendees may have regarding their current practices
Who can Benefit:
Quality Assurance
Quality Control
Manufacturing
Production
Regulatory
Laboratory Personnel
Management
Equipment vendors
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