Compliance4All, Online
2017-02-17
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
|