The FDA’s 21 CFR Part 211.160 establishes the legal requirement for calibrating laboratory equipment. Now more commonly referred to as Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), the qualification of equipment in a GMP Laboratory in the Pharmaceutical and Bio Pharmaceutical manufacturing operations are essential parts of the overall validation process and ongoing commercial batch release. Data generated in a GMP Laboratory cannot be considered valid if the acceptable performance of the instruments and equipment has not first been demonstrated.
This training course will discuss the differences between the IQ, OQ and PQ for laboratory instruments and how these qualification tasks differ. This training will also address their importance in demonstrating that laboratory instruments and equipment are fit for use.
Upon completion of this course, you will be able to:
This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.
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This course is intended for professionals such as Engineers, Technicians, Department Heads, Teachers, Scientists, Validation Engineers and Consultants working in Academia, the Pharmaceutical Industry, Analytical Laboratories and Contract Laboratories .
Those involved in Quality Control/Quality Assurance, Tech Services, Validation and Process Development will benefit greatly from this training. Managers and supervisors of these individuals will benefit by understanding the challenges sometimes faced in their departments.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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