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
Sunshine Act Reporting - Clarification for Clinical Research
How to Deal with Employees Who Love to Argue and Debate Eve…
Project Management for administrative professionals
ChatGPT and Project Management: Leveraging AI for Project M…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Terminating Toxicity: Strategies For Leaders To Confidently…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Reprogramming your mind for Corporate Excellence: 4 Steps t…
How to Write Effective Audit Observations: The Principles f…
How to Manage the Legal Landmine of the FMLA, ADA and Worke…
Uplifting the Credibility of HR: How to Build the Credibili…
Performance of Root Cause Analysis, CAPA, and Effectiveness…
Bridging Generational Divides in the Workplace
Strategic Interviewing & Selection: Getting the Right Talen…
Onboarding Best Practices for Millennial and All Employees
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
FDA Audit Best Practices - Do's and Don'ts
Emotional Intelligence: Mastering the Emotions of Great Lea…
Unlock Employee Loyalty: Stay Interviews Will Keep Them Eng…
Accounting For Non Accountants : Debit, Credits And Financi…
Successful Strategies for FDA Expedited Pathways for Your D…
Regulation update Q1 2025: New and Proposed Regulations for…
Pay Transparency in Action: Strategies for Building Trust a…
Designing Employee Experiences to Build a Culture of Compli…
Developing and Implementing Quality Culture in the Organiza…
Excel Lookup Functions: VLOOKUP, HLOOKUP, and XLOOKUP Made …
Break Free from Toxicity: Reclaim Your Power and Peace
Tips and Techniques for Conducting an Effective Fraud Risk …
Physician Employment Agreements: Problem Areas that can be …
Measure the Effectiveness of Compliance Programs by Engagin…
FDA Regulation of Artificial Intelligence/ Machine Learning
Navigating 2025 Employment Laws: What Every Employer Needs …
Implementing an Effective Human Error Reduction Program
Cleaning Data without Complex Functions - A Course for Data…
Succession Plan for 2025: It's Not Just for Emergencies - I…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Using High-Performance Coaching for Managers to Address Per…
6-Hour Virtual Seminar on Learning the Highlights of Excel …
Principles & Practices for the Cybersecurity of Legacy Medi…