Gaining and re establishing control of your cleanroom
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Gaining and Re-establishing Control of your Cleanroom PowerPoint PPT Presentation


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. 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.

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Gaining and Re-establishing Control of your Cleanroom

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Gaining and re establishing control of your cleanroom

Gaining and Re-establishing Control of your Cleanroom

Speaker: Joy McElroy| Date: 17th October 2016 2016 2016 | 10:00 AM PST | 01:00 PM EST

Contact Us : Email: [email protected] | Tel: +1-248-233-2049


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.

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.

Description:


Areas covered in the session

  • 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

Areas Covered in the Session:


Who will benefit

  • QA and QC managers

  • Disinfectant validation managers

  • Operations managers

  • Cleanroom managers

  • Personnel and contractors

  • EH&S managers

  • Regulatory compliance managers

  • Environmental monitoring managers

Who will benefit:


Instructor profile

Joy McElroy 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 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 written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. 

Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.

Instructor Profile :


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