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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407