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Ref : 28975
Event :FDA Regulations for Environmental Monitoring (EM) Program

Date :Monday March 04th, 2019

Location :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, United States

Type :Conference & Seminar - International audience

Accreditation :--


 

Further information

Editorial

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.

Objectives

Upon completion of this training, participants will be able to:

  • Describe how clean room environmental monitoring program fits into the regulations
  • Explain the basis of the four 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

Program

  • 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
  • Processing a Completed Environmental Monitoring Test Media
    • Sample Handling and Incubation
    • Documentation and Data Management of EM Test Results
    • What is the EM Test Data Used For?
    • Retention of EM Test Results
    • Interpretation of EM Test Results
  • Basics of Designing an Effective and Compliant EM Trend Reports
    • Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
  • Basics of Designing an Effective and Compliant EM Excursion
    • Handling EM Excursion Investigation
    • Handling Impacted Manufactured Batches
    • Disposition of Affected Products with Failed Clean Room EM Test Results
  • Corrective and Preventative Action (CAPA)
    • Relationship between CAPA and EM Test Data Excursion Investigations

Speakers


Joy McElroy
Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy McElroy 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, Ms. McElroy 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, she moved into equipment qualification and cleaning validation at Mallinckrodt.

With over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

In 2013, Ms. McElroy 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.

 
 

Location

Map and directions
Conference address :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
United States
tel : +1-888-717-2436
Map and directions

Further information

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Details

FDA Regulations for Environmental Monitoring (EM) Program Hospital - Management & Taxation
environmental monitoring training program, em program basics, pre-qualification and post-qualification em, em excursion program and capa, clean room transitional monitoring
Professionals, Quality Control Quality Assurance Microbiologists, Facilities Chemists, Analysts Manufacturing Validation Facilities Materials Management Engineering Sterility Assurance Compliance Testing Technicians Environmental Testing Personnel Raw Materials Manufacturers Clinical, Research and Development Laboratories Vendors/Suppliers Regulatory Affairs All Levels of Management
10 -- --
English

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