Conference Description:

It is no surprise to anyone who reviews regulatory citations to notice the number of deficiencies cited that are associated with quality systems. Today, the basis for all FDA audits both within the US and internationally is based on the quality systems approach and the six systems that comprise it. Whether the audit is a full or partial audit, the quality system within a company will always be inspected and this seminar will help review what are the expectations and the common areas to be familiar with. As a basis for regulatory audits, the quality system, its procedures and their implementation are reviewed to help verify the level of effectiveness in assuring consistent control and quality of materials, components and final product.

Learning Objectives:
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

Who will Benefit:
This course is designed for people within the quality unit, those impacted by quality requirements, third party suppliers who are evaluated against quality issues and their adherence to them, along corporate management who is required to provide the time and resources to correct quality issues identified. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance. Following personnel will benefit from the course:

Senior quality managers
Quality professionals
Regulatory professionals
Compliance professionals
Production supervisors
Manufacturing engineers
Production engineers
Design engineers
Process owners
Quality engineers
Quality auditors
Document control specialists