Webinar
Time
Webinar length
60 Min
USP is being revised to focus on risk-based methodologies in alignment with the digital connectivity available in many of today’s Analytical Instruments and Systems.
Apply Group A/B/C risk classes; PQ vs SST
Spot qualification gaps in multi-vendor systems
Apply a risk-based AIQ/CSV boundary framework
Assess vendor protocols for full coverage
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USP is the clearest signal that qualification and software validation are converging
- Robert Beane, Partner, BW Design Group
Partner, BW Design Group
Rob has nearly 30 years of experience leading turn-key capital engineering, validation and quality projects for pharmaceutical, biotechnology, and medical device clients. He has been with BW Design Group for almost 14 years assisting to build the Regulatory Compliance business and new service offerings for the company.
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