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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

CAPA Considerations: Problem Statement Writing and Investigation Techniques

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

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

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:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
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Price: $1200.00

Medical Device Single Audit Program (MDSAP)

This virtual instructor-led one-day course covers the rationale for developing the Medical Device Single Audit Program (MDSAP), who the participating regulatory authorities are, and the specific audit criteria (including country-specific requirements) used during MDSAP audits.

This course discusses, in depth, the audit approach used by recognized MDSAP auditing organizations (AOs) as well as the MDSAP nonconformity grading system. Learners will also identify what MDSAP audit findings may trigger action from a participating regulatory authority.

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

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This fast-paced instructor-led one-day course covers the basic concepts of planning, conducting, and reporting a medical device quality management system (QMS) audit in accordance with ISO 19011:2018. It is a must for auditors at all levels of the organization, as well audit program managers.

This course covers how to apply fundamental auditing strategies to any QMS scheme, as well as how to identify and grade nonconformities and prepare a medical device audit report in accordance with the identified criteria. The course also focuses on applying these fundamental principles when auditing a medical device manufacturer’s quality management system.

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

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    • Quality system standards
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Who Should Attend
This ISO 19011:2018 audit training is helpful for all auditors and all management personnel with responsibility for medical device regulatory life cycles, including involvement with the design and implementation of quality management systems or oversight of an internal or supplier auditing program.

Price: $800.00