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
Who should Attend
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
Past Events
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations - Sep 2020, United States (87148)
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations - 23-24 Sep 2019, San Francisco, California, United States (87147)
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations 2017 - 28-29 Sep 2017, Newark, New Jersey, United States (70202)
Important
Please, check "FDA Audit, Quality Assurance Practices, Responsibilities and Expectations" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical technology, Pharma
