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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.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
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 90-minute accredited 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.
This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program.
Attend this as a step in the certification process or as a stand-along course for personal career advancement and training.
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.
This training is Part of a 10-course series required for the GMP Laboratory Control Professional Certification Program.
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David E. Wiggins
Analytical/Stability Consultant
David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.
Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions, ANDA submissions and FDA general and PAI inspections.
Mr. Wiggins has over 35 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.