Gaining And Re-Establishing Control Of Your Cleanroom

Starting up a new cleanroom and releasing it for manufacturing involves a series of critical steps, and losing control after an excursion can halt production. This webinar on gaining and re-establishing control of your cleanroom covers both situations.

You'll walk through the steps to start a new cleanroom operation and the steps needed to release it for manufacturing, along with routine cleaning and disinfection strategies, current equipment and application methods, utilities, contamination and environmental monitoring.

Using a case study approach, the session then looks at excursion events and how to re-establish control of the cleanroom after a worst-case event.

• Follow the critical steps to start up a new cleanroom
• Release a cleanroom for manufacturing
• Set routine cleaning and disinfection strategies and choose equipment and application methods
• Respond to excursion events using lessons from case studies
• Re-establish control of the cleanroom after a worst-case event

• Critical steps in starting a new cleanroom operation
• Critical steps to release the cleanroom for manufacturing
• Routine cleaning and disinfection strategies, equipment and application
• Utilities
• Contamination
• Environmental monitoring
• Excursion events, with case studies
• Establishing control of the cleanroom after a worst-case event

FDA and EMEA regulated companies must validate their cleaning and disinfection programs and keep cleanrooms under control. This session helps pharmaceutical, biotech and medical device teams bring new cleanrooms online and respond well when things go wrong.

It suits QA and QC, operations, cleanroom, disinfectant validation, EH&S, regulatory compliance and environmental monitoring managers, and staff and contractors who clean and disinfect cleanrooms.

• This 90 minute webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs, including companies in the pharmaceutical, biotech, and medical device fields. The employees who will benefit include:
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• QA and QC managers
• Disinfectant validation managers
• Operations managers
• Cleanroom managers
• Personnel and contractors that clean and disinfect cleanrooms
• EH&S managers
• Regulatory compliance managers and environmental monitoring managers

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing environmental monitoring and sterility testing after earning a degree in zoology at North Carolina State University. She moved 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, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. Joy’s knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. She specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Joy 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.