Auditing is a critical function within a pharmaceutical company. It provides management with information about how effectively the company controls the quality of their processes and products. Auditors must perform their jobs competently to ensure their company’s compliance with pharmaceutical USFDA GMP regulations and other quality standards like ICH Q10. Module 1: Introduction to auditing and Audit preparation
Auditing for GMP is specifically designed to address the challenges of GMP auditing for the pharmaceutical industry and present the basic competencies required to effectively perform the auditor's assigned responsibilities and contribute to the improvement of auditor performance within a regulated industry.
The course includes a supplemental module that provides guidance in preparing for regulatory GMP inspections and is designed to provide broad fundamental industry knowledge through a customized learning experience for individuals that want to expand their cGMP knowledge.
Immediately apply the course learning objectives with pre and post assessments, downloadable course presentation for note taking, learning reviews highlighting important points, hot-links to regulatory and industry information, and an online resource handout as a quick reference for all web links discussed.
Approximate Course Duration: 2 Days (this is a self-paced course)
*NOTE* You will have 14 calendar days to access and complete this course from time of purchase. ?
Module 2: Attributes and experiences of a good auditor
Module 3: Steps and activities for successful audits
Module 4: Post-audit activities and follow-up
Module 5: Inspection points to consider during an audit
Module 6: Interesting points often missed
Module 7 (Supplemental): Preparing for Regulatory GMP Inspections
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