This 90-minute 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, setting alert and action limits, Documentation, Management and Trending of Data, EM Excursion investigation and Product Impact and Disposition will be discussed.
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 • How to set alert and action limits and Explain the relationship between an EM Excursion Program and CAPA
Who will benefit:
This webinar will provide a great resource to product manufacturers with personnel in the Pharmaceutical, Biotechnology, Biologics, Drugs, Diagnostics, Cell Therapy, and Medical Device Industries.
Course Outline: Agenda
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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 10 years of experience as a consultant, and 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. In 2013 Joy 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.