FDA Audit, Quality Assurance Practices, Responsibilities and Expectations is a conference that covers topics such as:
- Quality areas that are the point of focus during regulatory, corporate or third party audits
- Regulatory expectations of the quality unit and its role in the Quality System Requirements (QSR)
- The importance of training, its documentation, and common concerns being raised over "operator error"
- Typical checklist that can be used as a template for the performance of audits
- The current focus on data integrity issues and the current guidance document regarding it
- The importance and regulatory guidance offered for the investigation of deviations/out-of-specification results
- Weaknesses of each person`s current quality system and possible recommended corrective actions
- Top 10 most commonly cited drug GMP deficiencies for 2015-2016
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations brings together:
- Quality professionals
- Senior quality managers
- Compliance professionals
- Regulatory professionals
- Manufacturing engineers
- Production supervisors
- Design engineers
- Production engineers
- Quality engineers
- Process owners
- Document control specialists
- Quality auditors