Data Integrity: Overview and Documentation Completion, Review and Approval

On-Demand

Course Overview

Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements. This eLearning course is aimed at anyone working in the Pharmaceutical Industry and provides an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle.

Additional Recommended Courses

Preparing for FDA Medical Device Inspections – Practical Guidance (Advanced)

Understanding what to expect during an FDA inspection enables a medical device manufacturer to prepare effectively for an FDA inspection. This course is designed to meet the needs of domestic and foreign medical device manufacturers doing business or intending to do business in the United States. This course focuses on group activities designed to identify the key elements of Level 1, 2, 3 and For Cause inspections; preparing for and hosting an FDA inspection; review FDA databases (MAUDE and Recall) to identify and understand the focus of an FDA For Cause inspection; review the preamble and QSIT Guide to understand how to prepare for an inspection of the primary subsystems contained in QSIT; develop effective FDA 483 responses; and prepare in advance information needed by the investigator to complete an EIR (as described in the IOM). This course is designed to benefit your organization’s quality professionals responsible for preparing for, facilitating, and responding to FDA inspections; as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

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Who should attend
This course benefits quality professionals responsible for managing, facilitating, and participating in FDA inspections, as well as those responsible for defining, documenting, implementing, and maintaining an effective quality management system.

This course is important for medical device professionals, especially those who conduct or participate in any project and/or quality management system activity.

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CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

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This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

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This course pairs well as a prerequisite to MDSAP Internal Auditor Training (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

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Price: $800.00