Few people know the territory of Quality Assurance, Regulatory Affairs and Validation as well as Eric, in both the domestic and international sphere. Eric's specific areas of expertise include facility design, set-up, validation, and management per cGMP requirements, internal and external cGMP and Quality Systems audits. Eric has performed "mock" pre-approval inspection audits, directed corrective actions and acted as company representative to the FDA. Twenty years experience with major pharmaceutical companies makes even the most tangled routes in regulatory affairs seem like a walk in the park.