Description:
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 addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.
Objective:
Upon completing this course participants should:
• 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.
Outline:
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
• Case studies regarding excursion events
• Excursion investigations and troubleshooting parameters
• Questions
Target Audience:
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
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy 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 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, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has consulted numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Novartis, and Baxter.
Joy 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.
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 addressed. Addressing contamination and bringing up the cleanroom after a worst case event will be discussed. Cases studies on bringing up the site after a worst case event will be detailed. Excursion investigations and troubleshooting parameters and suggestions will also be discussed.
Objective:
Upon completing this course participants should:
• 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.
Outline:
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
• Case studies regarding excursion events
• Excursion investigations and troubleshooting parameters
• Questions
Target Audience:
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
Instructor Profile:
Upon earning a degree in Zoology at North Carolina State University, Joy 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 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, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has consulted numerous companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Novartis, and Baxter.
Joy 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.
