Gaining And Re-Establishing Control Of Your Cleanroom

Recorded Session
60 Minutes

OVERVIEW

    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 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.

Area Covered

    • 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
    • Establishing control of the cleanroom after a worst case event
    • Excursion events

Who will benefit?

    • 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:
    •  
    • 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
Webinar Option
Transcript
Downloadable Recorded Session
Training CD

Speaker Profile

ins_img Joy McElroy

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 …