Gary Bezner

Background

About Gary Bezner

Over 40 years of professional expertise in pharmaceutical product manufacturing and packaging technical services support. Specialization in the validation of production equipment, facilities and controlled environments, cleaning procedures, manufacturing processes, and shipping package design. Knowledge of pharmaceutical manufacturing and packaging processes for solid oral dose, aerosol, suppository, topical, liquid, and combination drug device products. Proven excellence in creating new corporate validation programs and improving existing quality systems, as well as in providing innovative solutions to challenging validation projects. Demonstrated success with technical support of existing product maintenance functions, including formulation modifications, process improvements, and exception event investigations. Technical validation consulting services provided for internal and external partnership projects. Over 15 years direct managerial experience of departmental staff and resources. Effective leadership experience with a management strategy focused on strong customer support, team-oriented, and risk-based approaches for achieving shared business objectives. Demonstrated strength in leading, organizing, and motivating project teams toward successfully completed objectives. Working knowledge of CGMP, EU, ICH, ISO, and ASTM standards and regulations. Proven technical support of validated marketed products including root cause investigations, change control, and process control risk management. Experience with non-sterile and sterile pharmaceutical and medical device manufacturing environments.