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
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 Program - Types; Content - 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 Question and Answer Session
Who Will Benefit:
Environmental Testing Personnel
Raw Materials Manufacturers
Clinical, Research and Development
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.