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.
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
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
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
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.
- 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
- 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
- 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
Speaker Profile

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 …
Upcoming Webinars

How to Write Contracts for Procurement Professionals

Impact Assessments For Supplier Change Notices

Stay Interviews: A Powerful Engagement and Retention Tool


Harassment, Bullying, Gossip, Confrontational and Disruptiv…


FDA Regulation of Artificial Intelligence/ Machine Learning





FORM I-9 2022: ICE Announces New Extension Date and Require…

Establishing a Robust Supplier Management Program

Three Key Risk Assessments in Your ERM Program - ERM IT and…

With Mandatory Paid Leave Gaining Ground, Is It Time To Do …

Project Management for Non-Project Managers

Travel and Expense Policy Development and Automation

Utilizing HR Metrics to Illustrate & Improve Human Resource…


Implementing an Effective Human Error Reduction Program


How to prepare an effective audit manual for an internal au…


CMO Supplier Quality Agreements: How to Comply with new FDA…

Form 1099 Update 2022: Latest Forms, Rules and Reporting Re…

21 CFR Part 11 - Compliance for Electronic Records and Sign…

Managing Toxic & Other Employees Who have Attitude Issues

The Importance of Packaging and Labeling in Pharmaceutical …

I-9 Audits: Strengthening Your Immigration Compliance Strat…


Building a World Class Accounts Payable Operation: P2P, AP

The Top Ten Excel Functions Everyone Should Know
