2020 - FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

Upon completing this course participants should:
Understand the regulatory expectations of the quality unit and its role in the Quality System Requirements (QSR)
Review the Quality areas that are the point of focus during regulatory, corporate or third party audits.
Review typical checklist that can be used as a template for the performance of audits
Evaluate the importance of training, its documentation, and common concerns being raised over "operator error"
Review the importance and regulatory guidance offered for the investigation of deviations/out-of-specification results.
Review the current focus on data integrity issues and the current guidance document regarding it
Review the top 10 most commonly cited drug GMP deficiencies for 2015-2016
Understand the weaknesses of each person's current quality system and discuss possible recommended corrective actions