Environmental Monitoring (EM) Program Basics
Wednesday, March 21 2018 10:00 AM PDT | 01:00 PM EDT
Training Duration = 60 Min Sponsored by Compliance Online
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program.
The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
Why Should You Attend:
This 90-minute webinar will discuss various broad and critical aspects of an effective EM program such as the phases of a cleanroom EM program–pre-monitoring of a cleanroom prior to facility validation, implementation of routine EM using facility validation data and post-validation.
Procedural steps, content of a robust EM program such as handling, incubation, documentation, management and trending of data, EM excursion investigation and product impact and disposition will be discussed
Upon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
In 2013, Ms. McElroy 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.