Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

Duration: 90 Minutes
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.
Audits for Data Integrity
Instructor: Joy L McElroy
Product ID: 509850
Objectives of the Presentation
  • 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
Why Should you Attend
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.

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
Topic Background
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.
$375
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.

With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest.

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing.

In 2013 Joy started, Maynard Consulting Company, which provided engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off site training to pharmaceutical and biotech companies throughout the United States, Canada, and the world.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.
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