Critical Role of Quality Audit in GxP Compliance & Improvement (FDA)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Sep 29, 2010 End Date/Time: Sep 29, 2010
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Learn the basic skills required and how to apply them and the knowledge in becoming more effective.
Manufacturers need to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as well as assessing your GCP, GLP and GMP programs. Quality audits need to be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, need to be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, will be made and such reports certainly will be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits must be documented. This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.

Areas Covered in the seminar:

Understand that audit preparation is critical and how to generate the audit plan.
Learn the different type of audits and how to prepare, execute and close out the audit.
Selecting your auditor or audit team and knowing the source of authority for conducting the audits.
Development of checklists and using data collection methods.
Know the expectations for audit performance, execution and auditing techniques.
Understand the rules and expectations for audit reporting, corrective action, follow-up and closure .
Learn the Do’s and Don’ts when auditing as related to FDA investigators/inspectors during inspections at your facilities.
Understand the code of ethics, expectations, and how to write an effective audit report summarizing your findings.


Online Event
2600 E. Bayshore Road
Palo Alto
United States