This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
Learning Objectives:
- The critical steps needed to release the room for manufacturing will be discussed
- Routine cleaning and disinfection strategies will be covered as well as the latest in equipment and application
- Establishing control of the cleanroom after a worst case event
- Excursion events will be discussed and case studies will be covered regarding excursion events
Why Should You Attend:
This webinar will focus on starting up a new cleanroom operation covering everything from utilities to environmental monitoring. Routine cleaning and disinfection will also be covered. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed along with the case studies.
The webinar will further discuss the excursion investigations and troubleshooting parameters and suggestions.
Topics
- Critical steps in starting a new cleanroom operation
- Critical steps need to release the cleanroom for manufacturing
- Routine cleaning and disinfection strategies
- Utilities
- Contamination
- Environmental monitoring
- Excursion events
- Case studies regarding excursion events
- Excursion investigations and troubleshooting parameters
Instructor
Upon earning a degree in Zoology from 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 of 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.