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Performing Effective and Compliant Failure Investigations and writing CAPAs

Summary

  • Regulations guiding manufactured product sterility testing and how to ensure adherence to program testing requirements.

  • Conducting sterility test failure investigations and what to look for during investigation process.

  • Role of contamination such as microbial identification of contaminants and its importance.

  • Retest during a sterility failure investigation and how to apply corrective and preventative actions based on a sterility failure investigation.

  • Dispositioning impacted products based on investigational findings while avoiding common mistakes during product disposition.

  • Impact of sterility failure investigation for commercially distributed products under a stability testing program.

Overview

This webinar program will disclose how to prevent mistakes by implementing a robust CAPA program. Errors and inaccuracies made when corrective and preventative actions are not clearly recognized and applied during sterility test failure investigation will be discussed. Many times  ineffective investigational procedures and tools are used to conduct a sterility test failure investigations. The webinar will also explain how avoiding common mistakes will ensure that manufacturers meet the sterility requirements USP <71> and other regulatory guidelines applicable to their finished products, bulk drug substance, raw materials or excipients

Why should attend?

  • Quality Control Managers
  • Quality Assurance
  • Manufacturing/Production Operators
  • Senior Management
  • Supplier Quality
  • Regulatory Affairs
  • Quality Control Analysts
  • Facility, Maintenance and Engineering Personnel
  • Consultants

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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