FDA Regulations for Environmental Monitoring(EM) Program

  • April 05, 2017
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FDA Regulations for Environmental Monitoring(EM) Program

Overview: 
Upon completion of this training, you will be able to 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

Why Should You Attend:
The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for Cleaning Validations of your manufacturing equipment?

Areas Covered in the Session:
Applicable Regulations - Where does the EM Program fit in the Regulation? - Role of Clean room Environmental Monitoring Program?
Basics of Setting a Robust and Effective EM Program - Key Considerations - Relevant Material Verification Processes - Steps and Content of an EM Program Testing Procedure

Who Will Benefit:
Quality Control,
Quality Assurance
Microbiologist, Facilities
Chemist, Analysts
Manufacturing
Validation
Engineering

Speaker 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.


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