Performing Effective and Compliant Sterility Failure Investigations
  • CODE : JOYM-0018
  • Duration : 90 Minutes
  • Level : Intermediate
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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 through implementing 5 simple techniques she has learned and applied through the years.

This 90-minute 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

Areas Covered

  • 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 the 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

Course Level - Intermediate

Who Should Attend

  • Quality Control and Quality Assurance Professionals
  • Production Personnel
  • Manufacturing Supervisors
  • Mangers
  • Microbiology Analysts

Why Should You Attend

The objective of this webinar is to provide an understanding of the regulations for sterility testing programs and the process of conducting an effective, robust and compliant sterility test investigations for various types of products.

  • $179.00

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