Alex Wegner - Performance Validation

Alex has supported cGMP compliance projects for the medical device industry since 2014. His area of focus in medical device manufacturing is overall quality compliance. His experience includes operations engineering, nonconformance management, design and product risk analysis, process improvements, process validation, and equipment qualification. He also has experience with ensuring compliance of a developed UDI Label to the FDA Regulation 21 CFR Part 830.

Brad Henry

Vice President of Services Products - Brad has over 20 years of experience managing and executing CQV projects for the pharmaceutical and medical device industries. He has extensive experience in dry products, parenteral, facilities and utilities, and in-vitro diagnostics.

Schedule with Brad Henry