Charisma

#	Content
1	Module 1: Regulatory Framework & Compliance
2	Module 2: Cleaning Process Design & Chemistry (Lifecycle Stage 1)
3	Module 3: Risk Assessment & Matrix/Bracketing Approaches
4	Module 4: Acceptance Criteria & Residue Limit Calculations
5	Module 5: Analytical Methods & Sampling Strategies
6	Module 6: Protocol Execution & Qualification (Lifecycle Stage 2)
7	Module 7: Continued Verification & Change Control (Lifecycle Stage 3)

#	Outcomes
	• Understand Regulations: Learn global compliance standards like FDA, EMA, and ICH guidelines for cleaning validation.
	• Master the Lifecycle Approach: Gain the ability to design, validate, and maintain cleaning processes across three distinct stages (Design, Qualification, and Continued Verification).
	• Calculate Residue Limits: Learn how to scientifically establish safe acceptance limits for active pharmaceutical ingredients (APIs), detergents, and microbial residue.
	• Design Worst-Case Scenarios: Identify worst-case products, equipment trains, and hard-to-clean areas to streamline testing protocols.
	• Validate Analytical Methods: Know how to develop and validate analytical methods (like TOC or HPLC) to reliably detect trace residues.
	• Manage Risk and Deviations: Apply risk-assessment tools (such as FMEA) to evaluate changes, troubleshoot cleaning failures, and handle deviations effectively.

#	Participants
1	� • Quality Assurance (QA) and Quality Control (QC) professionals
2	� • Validation and Compliance Managers
3	� • Manufacturing and Production Supervisors
4	� • Process and Facilities Engineers