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

Date : 28th September 2017 to 29th September 2017

Place : United States, New jersey

Website :https://www.eventbrite.com/e/fda-audit-quality-assurance-practices-responsibilities-and-expectations-com-tickets-35062004399?aff=NDT

Contact Person:Paula Edwards

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

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 will be held in New jersey,United States on date 2017-09-29

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Deadline for abstracts/proposals : 8th September 2017

Keynote Speakers : Kenneth Christie, Chief Operating Officer, VTS Consultants Inc and ISPE Examination Development Committee (EDC) Member Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of quality assurance and validation management in the pharmaceutical and biotechnology industries.

Conference Highlights :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"

Venue :Jersey City, NJ, United States

Check the event website for more details.