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Advanced Auditing Strategies for Data Integrity Risks

Duration : 90 Minutes

Joy L. McElroy,

Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more

Any successful records management plan will start with a benchmark assessment of your current state followed by a data integrity audit. This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.

Auditing is a critical aspect of an overall data integrity assurance plan. To successfully audit the integrity of data, auditors must possess specific knowledge, insights, and skills. A solid audit strategy and plan are critical to providing the highest degree of assurance that no data integrity breaches have occurred, short of 100% verification (which is unfeasible in an industry that generates large volumes of data).But first, an auditor must understand what to look for before embarking on a data integrity audit. It is important to focus on high-risk areas within a dataset, since these provide the greatest opportunities to identify issues in the limited time available.

Course Objective:

Where are your records, what are the formats, how are they being tagged and classified, what kinds of policies are you applying to management and how well and consistently are you enforcing those policies?

This webinar will help attendees learn how to apply consistent Meta tags and policies to all documents and records. It will also teach how to reduce compliance and e-discovery risks.

This webinar is designed for people tasked with performing audits for their organizations for data integrity. It is also for those tasked with records management. This includes individuals that have Quality Management Systems responsibilities for making general improvements in their organization's performance specifically related to equipment that produces and stores data, processes and documentation.

Course Outline:

• Establishing a Baseline
• Applying consistent meta tags to all documents
• Applying consistent policies to all records
• Achieving a best practice level of compliance
• Inspecting Live Computer Systems for Data Integrity Controls
• Pattern Recognition Methods
• Flags for Parallel Record-Keeping
• Evaluating Data Governance Programs
• Data Process Maps and Data Life Cycle Assessments
• Centralizing management and eliminating silos
• Evaluation of Current Enforcement Trends, including FDA & EU citations
• Reduce compliance and e-discovery risks
• Building a better business case

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Senior Quality Managers
• Quality Professionals
• Regulatory Professionals
• Compliance Professionals
• Production Supervisors
• Validation Engineers
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners
• Quality Engineers
• Quality Auditors
• Document Control Specialists

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register


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Subject : Advanced Auditing Strategies for Data Integrity Risks

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