FDA Expectations for 503B Outsourcing Facilities

Doyle Smith, Compliance Specialist, Compliance Insight, Inc.

An experienced Compliance Assurance professional with a diverse background, with over 24 years as a FDA employee and over 20 years’ experience in the Pharmaceutical industry, having an in-depth knowledge and experience in the application and evaluation of GXP regulations. Possessing a broad based knowledge of the FD&C law and implementing regulations with extensive experience in the application of cGMP and GCP regulations / guidance in the establishment of drug development manufacturing, packaging and testing, investigations, document review and evaluation and auditing. As well as, training, and participating on multidisciplinary teams. Responsible for the planning and audit execution of the audit programs; organizing and leading people and projects to produce timely results. A self-motivated individual who is a team player and enjoys a challenging work environment.