Establishing and Regaining Control of Cleanroom

Sorry, registration has ended.

Faculty: Joy McElroy ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB3055

  • Date:6/12/2023 11:00 AM - 6/12/2023 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

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.

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 clean room after a worst case event.
  • Excursion events will be discussed and case studies will be covered regarding excursion events.

Areas Covered in the Session :

  • Critical steps in starting a new clean room operation
  • Critical Steps need to release the clean room for manufacturing
  • Routine cleaning and disinfection strategies
  • Utilities
  • Contamination
  • Environmental monitoring
  • Establishing control of the clean room after a worst case event
  • Excursion events
  • Case studies regarding excursion events
  • Excursion investigations and troubleshooting parameters

Who Should Attend:

  • QA and QC managers
  • Disinfectant validation managers
  • Operations managers
  • Clean room managers
  • Personnel and contractors that clean and disinfect clean rooms
  • EH&S managers
  • Regulatory compliance managers and environmental monitoring managers

Course Director: JOY McELROY

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the 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 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence.

Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance.

In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States.

Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.