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Writing Effective IQ, OQ, PQ Protocols for Equipment Qualification

Summary

  • Regulatory Requirements for writing IQ, OQ, PQs

  • Components of an effective IQ, OQ, and PQ

  • Proper language used to author protocols and documenting test results

  • Collecting Data

  • Conducting Tests

  • Protocol Templates

  • Writing generic IQ, OQ, and PQ protocols

  • Obtaining necessary documentation

Overview

Regulatory Agencies expect Pharma, Biologics, and Medical Device manufacturers to maintain control over their equipment. The FDA and various other regulatory agencies are finding deficiencies with the qualification of analytical and manufacturing equipment.  A large number of the deficiencies occur due to poorly written IQ, OQ, and PQ protocols. Proper equipment qualification cannot occur without and effective protocols.

Why should attend?

  • Validation Engineers
  • Quality Assurance Personnel
  • Manager and Supervisors
  • Calibration and Maintenance Personnel
  • Technical Writers

Joy L. McElroy

Expert

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 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification.

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