Advanced Auditing Strategies to Detect and Mitigate Data Integrity Risks

  • Product Id : FDB3052
  • Category : , ,
  • Presenter :
  • Scheduled On : August 27 2020 1:00 pm
  • 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.

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.

Areas Covered in the Session :

  • 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
Who Should Attend:

  • 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

FDB3052

Joy McElroy

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 and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, 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, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

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.

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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
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