Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)

Course "Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Systems for Regulated Industries (Pharma, Biotech, Devices, etc.)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
This Seminar will address requirements of both Validation and Qualification activities in Pharma, Biotech and Device Industries, both for compliance to Regulations and industry specific guidelines. More particularly, with respect to Validation of Systems, it will introduce and enumerate a grass roots, basic, iterative pathway to Qualification (IQ, OQ, PQ) of Laboratory Equipment and Validation, which is very portable and widely applicable across the industries. A brief discussion on Qualification of various laboratory instruments and systems will also be touched upon, including current guidance from USP on Analytical Instrument Qualification processes. This Seminar will cover, with illustrations and examples, the various stages in Validation and Qualification of Laboratory Equipment and Systems with a Risk Based Strategy. The two day sessions will include a class breakout session (2.5 hours) for each of the 2 Days (in the afternoon), wherein the attendees will be given a group exercise topic relevant to the material, in practical demonstration of meeting FDA/EMA/WHO/ICH compliance requirements. These brainstorming, highly interactive sessions are useful to attendees in gaining practical knowledge, along with the comprehension of the subject matter.