I. Review the Fundamentals of Cleanroom Microbiology
II. Interpret Regulatory Expectations and Cleanroom Requirements
III. Create and Implement Dynamic SOPs for Cleanroom Processing
IV. Validate the Design and Operation of a Cleanroom Facility
V. Critique and Compare New Cleanroom Systems and Technologies
VI. Develop a Cleaning Validation Master Plan (CVMP)
VII. Conduct Analytical Practices of Cleanroom Environments
VIII. Establish Acceptance Limits for Products, Components and Processes
IX.Use Proven Inspection Techniques for Cleanroom Regulation Compliance
X. Demonstrate Best Practices for Internal and External Auditing of Controlled Environments
XI.Prepare for an FDA Audit
XII. Prepare for Ongoing Internal Inspections
12(hours)