regulatory-considerations-for-pharmaceutical-cleanroom-em-program

Regulatory Considerations for Pharmaceutical Cleanroom EM - Program

Live Webinar

  • 90 minutes

This webinar will discuss various broad and critical aspects of an effective EM program such as the Phases of a cleanroom EM Program–Pre-Monitoring of a Cleanroom prior to Facility Validation, Facility Validation, Implementation of Routine EM using Facility Validation data and Post-validation. Procedural Steps, Content of a robust EM program such as handling, incubation, Documentation, Management, and Trending of Data, EM Excursion investigation, and Product Impact and Disposition will be discussed.

In this webinar join expert speaker Joy McElroy, where she will explain the relationship between an EM Excursion Program and CAPA.

Session Highlights:

  • Describe how Clean room Environmental Monitoring (EM) Program fits into the Regulations

  • Explain the basis of the Four (4) Phases of Clean room transitional monitoring (Pre-qualification through post-qualification EM) and what each type stands for

  • List the basic content of a well-designed, effective and compliant EM Program

  • Explain the relationship between an EM Excursion Program and CAPA

  • Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Clean room Environmental Monitoring Program?

Why You Should Attend:

We will discuss all current air & surface monitoring systems for the measurement of non-viable particulate, microbial contaminants in the clean room. The subject of clean room contamination due to personnel is discussed including both gowning technique and aseptic practices. Then ongoing monitoring practices for the clean room environment are discussed with respect to the sampling frequency, sampling locations, and the investigation of action level excursions. This is followed by a discussion of how environmental monitoring data is reviewed (Data Trend Reports) for product release.

Who Should Attend:

  • Quality Control

  • Quality Assurance

  • Microbiologist, Facilities

  • Chemist, Analysts

  • Manufacturing

  • Validation

  • Engineering

  • Sterility Assurance

  • Compliance

  • Testing Technicians

  • Environmental Testing Personnel

  • Raw Materials Manufacturers

  • Clinical, Research and Development

  • Laboratories


*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it as per your convenience.

Joy Mcelroy

Joy Mcelroy

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing. Joy work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 she moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, she moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 14 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, she has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing.

She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. She develops and delivers webinars, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more. Joy also writes articles on these topics for various online magazines.In 2013 she started my 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.

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