Advanced Auditing for Data Integrity
  • CODE : JOYM-0009
  • Duration : 90 Minutes
  • Level : Advance
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Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their 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 14 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, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.

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

In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.

Any successful records management plan will start with an assessment of your current state. Data Integrity audits will ask :

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?

Learning Objective

  • Learn how to apply consistent meta tags to all documents
  • Learn how to apply consistent policies to all records
  • Learn how to achieve the best practice level of compliance
  • Learn how to write effective SOPs for data integrity compliance
  • Learn how to reduce compliance risks

Who Should Attend

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Validation engineers
  • Manufacturing engineers
  • Production engineers
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • $179.00



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